Volume 28 Number 3

September 2019

Medical Writing

Trends in medical writing

Also in this issue...
• AMWA–EMWA–ISMPP Joint Position Statement on Predatory Publishing
 Editorial: Trends in medical writing 1 The 360° approach to authoring 56
Somsuvro Basu risk management plans
Sushma Materla
President’s Message 3
Barbara Grossman Trends in regulatory writing: 62
A brief overview for aspiring medical
Medical Writing is the official EMWA News 4 writers
journal of the European Medical Surayya Taranum
Writers Association (EMWA). It is a Feature Articles
quarterly journal that publishes The medical writing landscape 70
articles on topics relevant to Omics in silico and other trends in 6 in China
professional medical writers. biomedical research: Clare Chang
Members of EMWA receive Medical Impact on how and what we write
Writing as part of their membership. Raquel Billiones Regular Features
For more information, contact
[email protected]. Catching the wave of lifestyle medicine 12
Maria Carolina Rojido News from the EMA 74
Submissions:
For instructions to authors, go to the Artificial intelligence – 20 Regulatory Matters 78
journal section of EMWA’s website will we be replaced by robots?
(www.emwa.org). All manuscripts Martin Delahunty Medical Communications and 79
should be submitted to
Writing for Patients
[email protected].
Now more than ever, 22
Editor-in-Chief scientists must speak up for science In the Bookstores 80
Phillip Leventhal Melvin Sanicas • The Biomedical Writer
Co-Editors
Stephen Gilliver When less is more: Medical writers 24 Getting Your Foot in the Door 82
Evguenia Alechine as guardians of curated content • Wanted: A “medical writing for
Associate Editors Laura C. Collada Ali, Jackie L. Johnson, dummies" manual
Anuradha Alahari and Amy Whereat • How the EMWA community helped
Raquel Billiones me shape my career
Clare (Chi-Chih) Chang Predatory publishing – what medical 28
Barbara Grossman communicators need to know Veterinary Medical Writing 84
Jonathan Pitt Andrea Bucceri, Peter Hornung, and
Joselita T. Salita Thomas M. Schindler Medical Devices 86
Nathan Susnik

Section Editors AMWA–EMWA–ISMPP Joint Position 34 My First Medical Writing 88

Laura Collada Ali Statement on Predatory Publishing • Local photoablation of nerves to
Lisa Chamberlain James treat chronic pain
Jennifer Clemens How to combat medical misinformation 36
Kelly Goodwin Burri with a sound content strategy Journal Watch 90
Claire Gudex Diana Ribeiro and Mathew Wong
Wendy Kingdom
Good Writing Practice 92
Sam Hamilton
Subcontracting: 40
Laura Kehoe
Maria Kołtowska-Häggström
Not for the faint of heart Regulatory Public Disclosure 94
Alison Mcintosh Brian G. Bass
Hervé Maisonneuve Out on Our Own 97
Karim Montasser Lay summaries and writing for 46 • Growing as a freelancer through
patients: Where are we now and volunteering
Copy Editor/Reviewer
Amy Whereat
where are we going? • Getting into medical writing through the
Lisa Chamberlain James and Freelance Business Forum
Managing Editor Trishna Bharadia • Networking: The important part of the
Victoria J. White Freelance Business Forum
Editor Emeritus Clinical trial disclosure: Perspective 52
Elise Langdon-Neuner from a medical writer for a contract
research organisation
Vivien Fagan

September 2019 Medical Writing | Volume 28 Number 3

 Volume 28 Number 3 September 2019

Medical Writing
Trends in medical writing
It is my privilege to present you the Medical Writing special issue garnering presenting trustworthy information to clinicians or patients. The trio expands
the current Trends in the Medical Writing sphere. With the perpetual the discussion by providing tailored strategies designed for specific audiences.
amendments in the pharmaceutical industry and the ever-evolving The American Medical Writers Association (AMWA), European Medical
approaches in operating and disseminating biomedical research, we are Writers Association (EMWA), and International Society for Medical
witnessing a matching progression in medical writing. Be it battling the Publication Professionals (ISMPP) have recently released a Joint Position
rampant free-flowing medical misinformation in this post-truth world, or Statement on Predatory Publishing ,1 educating us about this malign practice.
public disclosure of clinical trials, or the drifts in manoeuvring artificial We are republishing it in this issue. On a similar note, Andrea Bucceri, Peter
intelligence and digital health, medical writers are prudently setting trends. Hornung and Thomas M. Schindler delve deeper into this topic making us
We have assembled these anecdotes, in the form of thirteen feature articles, aware of the severe consequences of publishing in these pseudo-journals.
which are gaining attention by diversifying the already-colourful medical Moreover, they propose several recommendations to evade being knuckled
writing arena. down by the predatory publishers.
In the opening piece, Raquel Billiones discusses the latest development Taking the proceedings forward, Diana Ribeiro and
in biomedical exploration (biohacking, combination products, vaccine Mathew Wong talk about the responsibility of
hesitancy, and many more aspects), which could eventually dictate the medical writers in creating a precise content
Be it battling
medical writers to modulate our stance. Maria Carolina Rojido enlightens strategy to crack the vicious puzzle of the rampant free-
us about lifestyle medicine: its importance in tackling non-communicable medical misinformation in this age of flowing medical
diseases, and the promising opportunities for the medical writers in this “fake news” and “viral pseudoscience”. misinformation in this
incubating field. Martin Delahunty walks us through the advancement in As a successful trendsetter and
artificial intelligence-based tools fitted to support the scientific and medical inspiration for the freelance medical
post-truth world, or
publishing in his insightful account “Will we be replaced by robots?” writers, Brian Bass highlights his public disclosure of
Content is king – we medical writers are aware of that. Nevertheless, a precious experience about building clinical trials, or the drifts
one-size-fits-all tactic will not help us achieve our goals. Then, how should medical writing business via the in manoeuvring artificial
we efficiently plan-develop-disseminate accurate and useful content for a subcontracting/outsourcing path. He
diverse readership under different state of affairs? The following four articles explains the pros and cons of the intelligence and digital
unravel the solutions: subcontracting practice, guidance that health, medical writers
Science communication offers researchers with an invincible power of could be an asset for the future sub- are prudently
story-telling their discoveries to a broad array of population. Melvin Sanicas contractors.
setting trends.
urges scientists to engage more with the public by protecting them from the In the next two articles, patients are at the
malady of misinformation. cynosure. Lisa Chamberlain James and Trishna
In this era of big data, keeping pace with the stockpiling scientific and Bharadia cover the practical details of writing a lay summary,
medical data is a painstaking task. As a resolution, the content curators come especially emphasising the challenges associated with the process and
into play, where they amass pertinent contents on a specific topic from a wide guidance for the medical writers to nurture the science-public alliance.
range of sources and serve it in a systematised fashion to respective clients. Vivien Fagan shares her fascinating journey from regulatory writing to be in
Laura C. Collada Ali, Jackie L. Johnson, and Amy Whereat shed light on the field of clinical trial disclosure. She elucidates the actions she has taken
the role of medical writers in content curation. Equipped with a blend of along the transition, being under the umbrella of a clinical research
analytical and writing skills, medical writers could act as content curators organisation.

www.emwa.org Volume 28 Number 3 | Medical Writing September 2019 | 1

 Volume
28 Numbe
r2
June 2019

Medical
Writing
It is challenging to stay abreast of the up-to-date regulatory practices in
the dynamic setting of pharmacovigilance legislation. To make your job easy,
Corrections to articles published
Sushma Materla put forward a comprehensive approach to write a risk in June 2019 Medical Writing
Generics
and biosim
management plan. Surayya Taranum illuminates the latest trends in Also in this
• ICMJE
issue...

• Collect
business
require
interventionalments for sharing
clinical trials
ing metrics
in medica
ilars
individual

l writing
participant
data from
• Docum – the benefit
ent manag s to you
ement system and your

regulatory writing, guiding us around the developments in EU regulations Because of a production error that occurred after
s for medica
l writing

for medical devices, data protection (General Data Protection Regulation the authors’ final review of the proofs, an incorrect
and EMA policy 0070), and the influence of artificial intelligence in the global symbol was displayed on p. 28 of the June 2019 issue of Medical Writing
medical writing market. Finally, Clare Chang explains the transforming (Volume 28, Number 2), in the article titled “Statistical principles in
regulatory medical writing scene in China, particularly upon China’s inclusion biosimilar development”.
as a member of the International Council for Harmonisation of Technical The error was not present in the print version of the journal but was
Requirements for Pharmaceuticals for Human Use. Moreover, she talks about online for some time before being corrected.
the striking growth at the Chinese popular science writing turf – a steady The null hypothesis is stated correctly below, with the symbol before
stride boosting societal science awareness. 1.25 correctly displayed as greater than or equal to.
Before summing up, I would like to thank all authors for their esteemed




contributions. I thoroughly enjoyed reading their edifying accounts. Big
thanks go to Evguenia Alechine and Victoria White for their relentless help
and support to put this issue together. I hope you find this issue of Medical


Writing interesting and enlightening, inspiring the trend-setting medical
– – – – –– – – – –
writer within you!
On p. 70, in the article titled “International Committee of Medical Journal
References Editors’ requirements for sharing individual participant data from
1. American Medical Writers Association; European Medical Writers interventional clinical trials”, the text incorrectly indicated that clinical
Association; International Society for Medical Publication trial sponsors must pay fees for participating in all data-sharing platforms
Professionals. AMWA-EMWA-ISMPP joint position statement on discussed. The platform Project Data Sphere does not charge fees.
predatory publishing. Curr Med Res Opin. 2019 Jul;35(9):1657–8. The corrected paragraph appears below and has been updated online.

Clinical trial sponsors pay a fee for participating in some of these

GUEST EDITOR platforms, which provide most of the services relevant to assessing
Somsuvro Basu, PhD
and processing the data sharing requests for IPD. These platforms
Science Communication Officer
help clinical trial sponsors meet the ethical obligations for sharing of
Central European Institute of
deidentified/ anonymised IPD. Some current data-sharing platforms
Technology (CEITEC)
include the ClinicalStudyDataRequest consortium,41 the YODA
in Brno, Czech Republic
Project,42 Vivli,43 Project Data Sphere (does not charge any fees),44
Manages the science magazine and DataCelerate.45 Furthermore, several other clinical data-sharing
CEITEC Connect platforms concentrate their efforts at a national or institutional level
Proud EMWA member since 2017
(e.g., US National Institutes of Health), or at a disease-specific level
[email protected]
(e.g., Alzheimer’s Disease Neuroimaging Initiative).46

Save the date: EMWA

Conference in Sweden

MALMÖ
November 7-9, 2019

https://www.emwa.org/conferences/future-conferences/

2 | September 2019 Medical Writing | Volume 28 Number 3

President’s Message
Dear EMWA Members
I was asked if the time between conferences is a
quiet time. Having been in post just over 2
months at the time of preparing this report, I can
most definitely state – NO! New initiatives are
regularly proposed and I am often reminded of
how active our EMWA members are, with their
great breadth of experience and knowledge,
boundless energy, and enthusiasm!
To note just a few recent actions and
initiatives:
l Members of the Ambassadors Group have

attended several career events and partici-

pated in a video for medics considering a
move to medical writing; check out the video,
which you can access through EMWA News
on the website.
l Also on the website, EMWA’s Resources for

Medical Writers are a considerable plus for its

members. Have you seen the recent addition?
Under General resources, the CCJ Checklist
for authors writing scientific manuscripts
provides lots of useful reminders.
l A Hebrew version of the Joint Position

Statement ( JPS) on the Role of Professional

Medical Writers has been added to the
collection of different language translations,
bringing the total to 12. Perhaps you can add
to this? We are looking for someone to zone!) and join in. With a wide variety of and Veterinary Medical Writing (newly
translate the statement into Arabic; if you can topics in both the current programme and in formed at the May conference), as well as the
help, please email me. the library of past webinars, something is sure MD SIG; these greatly contribute to planning
l A second JPS has just been finalised on the to be of interest. Many thanks to the Webinar the Expert Seminar Series and Symposium
hot topic of predatory publishing, which was Team, and thanks, of course, also to the held at each May conference.
the subject of a very interesting session at the presenters. l If you would like to be more involved with
Vienna conference in May. EMWA repre- l Education Committee (EPDC) members EMWA and can spare a little time, we are
sentatives worked closely with the American have worked with EMWA Head Office to always looking for more volunteers. Keep an
Medical Writers Association and the Inter- plan a diverse offering of workshops for the eye on EMWA News on the website and the
national Society for Medical Publication November conference in Malmö, Sweden. monthly Newsblast email for updates and
Professionals to produce the JPS. Hopefully, The EPDC also actively supports people opportunities. All are welcomed.
it will also be translated into several languages, developing new workshops. To help, they
so helping to widen its impact. have developed a new workshop proposal I am looking forward to seeing many of you in
l The CORE Reference development team has form and timelines for developing a work- Malmö at our 49th EMWA conference:
published in Research Integrity and Peer Review: shop, so that a potential workshop leader November 7–9, 2019. Registration is open – go
Critical Review of the TransCelerate Tem- knows exactly what is needed and when! If book! If you haven’t yet made up your mind
plate for Clinical Study Reports (CSRs) and you are considering giving a workshop, have about coming, check out the August webinar,
Publication of Version 2 of the CORE Ref- a look at the website. which can be accessed by both EMWA and non-
erence (Clarity and Openness in Reporting: l Several new workshops will be run in Malmö EMWA members.
E3-based) Terminology Table, available at including one in the increasingly important And if you cannot come to Malmö, remember
http://dx.doi.org/10.1186/s41073-019- area of Medical Devices, which will comple- to save the dates of our special 50th conference
0075-5. ment the work of the Special Interest Group in Prague next year: May 5–9, 2020.
l Webinars are now an established part of the for Medical Devices (MD SIG). We now have
offering to EMWA members. Grab a mug of five SIGs: Pharmacovigilance, Regulatory Barbara Grossman
coffee (or your lunch depending on the time Public Disclosure, Medical Communication [email protected]

www.emwa.org Volume 28 Number 3 | Medical Writing September 2019 | 3

EMWA News

AMWA-EMWA-ISMPP Joint Position Statement on Predatory Publishing released

On July 29, EMWA, together with the publishing process by failing to perform AMWA–EMWA–ISMPP position statement
American Medical Writers Association rigorous peer review and show little apparent outlines the damage predatory journals do to
(AMWA) and the International Society for regard for the ethical principles detailed in authors and to the scientific community as a
Medical Publication Professionals (ISMPP), guidelines such as the International whole and provides practical tips for spotting
issued a joint position statement on the Committee of Medical Journal Editor such journals. It also underlines the
dangers of predatory publishing (see p. 34 of Recommendations for the Conduct, responsibility we medical writers have for
this issue). Predatory publishers and journals Reporting, Editing, and Publication of ensuring that the manuscripts we work on are
exist purely for profit. They undermine the Scholarly Work in Medical Journals. The not submitted to predatory journals.

New translations of the AMWA–EMWA–ISMPP Joint Position Statement

on the Role of Professional Medical Writers
EMWA is also currently involved in translating another AMWA–EMWA– beyond. The position statement was recently translated into Hebrew by
ISMPP joint position statement on the role of professional medical writers. EMWA member Sharon Furman-Assaf. Originally published in English,
Issued in 2017, this position statement sets out ethical standards for medical the statement s now available from the EMWA website (https://www.
writers who help to develop scientific and medical publications. We are now emwa.org/ joint-position-statement) in French, German, Italian, Spanish,
spreading the word among non-native English speakers in Europe and Romanian, Portuguese, Hungarian, Ukrainian, Russian, Farsi, and Greek.

4 | September 2019 Medical Writing | Volume 28 Number 3

EMWA Ambassadors
participate in webinar on
careers in medical writing

As part of continuing efforts by the

EMWA Ambassador’s Programme to
reach out to new audiences in order to
promote medical writing and EMWA,
John Dixon and Abe Shevack took part in
a webinar organised by Medic
Footprints, an organisation focussed on
the various career opportunities available
to medical doctors. The target audience
was medics interested in exploring
careers outside of medical practice. Abe
spoke about what regulatory medical
writers do and the documents they write
to support clinical development in the
pharmaceutical industry. John talked
about transitioning from being a
practising surgeon to med comms
medical writing and about the spectrum
of careers in this area. Another speaker,
practising physician Vidhya
Kumaranayakam, spoke about how she
became, among many other things, a
book author and publisher. At the start of
the webinar, a short survey showed that
most of the attendees knew almost
nothing about medical writing. However,
after the presentations and a subsequent
Q&A session many of them indicated
that they were interested in finding out
more. MedComm Special Interest Group gets down to business
A recording of the webinar is available
on YouTube: As mentioned in the last issue of Medical members are encouraged to do the same.
https://youtu.be/vSJ5YWH-yOY. Writing, the MedComm Special Interest Group We believe that sharing the joint position
(SIG) was established at the spring conference statement with academia is crucial, because the
in Vienna to support publication activities of main victims of predatory journals are
EMWA members. The first activity of Med- university researchers who must publish to
Comm SIG members was to participate in develop their career or even keep their job but
development and review of the joint position may not always be fully aware of predatory
statement on predatory publishing. The Med- publishers’ practices. The MedComm SIG is
Comm SIG has also supported wide dis- actively looking for the best way to share the
semination of the joint position statement. joint position statement with academia and
MedComm SIG committee member Andrea welcomes suggestions from EMWA members.
Bucceri has liaised with Taylor & Francis to The joint position statement will be presented
enlarge statement advise to all librarians during a lunchtime symposium at the Malmö
subscribing to Current Medical Research & conference in November 2019 and information
Opinion (where the statement was first pub- regarding its impact and, possibly, evolution will
lished) and through Taylor & Francis social be shared at the Prague conference in May 2020.
media platforms. Other MedComm SIG mem- Stay tuned for further details!
bers have shared the joint position statement Andrea Rossi and
through their private contacts. Other EMWA Slavka Baronikova

www.emwa.org Volume 28 Number 3 | Medical Writing September 2019 | 5

Omics in silico and other trends in
biomedical research: Impact on
how and what we write
Raquel Billiones Synthetic biology
Takeda Pharmaceuticals, Zurich, Switzerland Systems biology, move over to give space for
synthetic biology.3 A recent feature in The
Economist states “life runs not on software and
Correspondence to: hardware but in all-ware… [making] it highly
Raquel Billiones resistant to human reprogramming”.4 But it can
[email protected] be hacked. By combining biology and enginee-
ring, synthetic biology enables us to hack, vaccines have
redesign, even create life. With the development become the focus
Abstract of the CRISPR/Cas9 technology, gene editing of controversy and
Medical writers and communicators write has never been easier, cheaper, and faster. hype in all forms of
about biomedical research. It follows that the Medicine is benefiting from synthetic biology, media and thus
latest trends in this field translate to new starting with finding cures for genetic diseases to deserve mention here.
trends in medical writing. This article regrowing or repairing damaged tissues and
provides a peek into the latest breakthroughs organs using 3D printers. Viral misinformation
and developments in biomedical research that On an industrial scale, synthetic biology What used to be a trend towards
can impact what and how we write. requires a high amount of resources that go vaccine hesitancy has become an
beyond test tubes. This is where biology meets all-out anti-vaccination (anti-vax)
artificial intelligence. Biological experiments can movement.
Introduction now be automated, as gene editing becomes a Anti-vax is likened to a digitally spread
As medical and scientific communicators, we digital rather than laboratory activity. This year, disease. This type of “viral misinformation”
write about breakthroughs and innovations in Swiss scientists created the first computer- is the biggest pandemic risk we are facing
biomedical research. The latest trends in these generated genome of an organism,5 a bacterium today, according to a Nature article, and it
fields translate to new trends in how we created in silico. is spread by a “digitally-enabled emotional
communicate. We have to continuously hone our contagion.”6 It is sad that this misinfor-
skills, broaden our vocabulary, Do-it-yourself biology mation overshadowed recent achievements
and expand our knowledge base.
To keep up with new Another side of the omics revo- in vaccine development, such as the first
In this article, I share a collection trends, we have to lution is do-it-yourself biology malaria vaccine made available this year.7
of my favourite trends. Terms continuously hone (DIYbio).1 The DIYbio move- Health agencies are trying their best to
written in bold italics are defined our skills, broaden ment literally originated like start reverse this trend. But the battle is being
in the glossary in Table 1. up tech companies, in biological fought mainly on social media. I would like
our vocabulary, and laboratories set up in garages to pay tribute to advocacy groups fighting
The brave new world expand our and kitchens of biohackers and the good fight, trying different public
of omics knowledge base. bio-innovators. Activities range outreach strategies to counteract anti-vax
In the era of omics (genomics, from home micro-breweries to thinking. Children’s book writer Andrew Murray
transcriptomics, proteomics, metabolomics)1 the “CRISPRing” marijuana, to culturing fluorescent (“Buddy & Elvis”) uses cartoons and animations
term biotechnology seems inane and inadequate bacteria for artistic purposes, to the more to increase awareness.8 One of his characters, my
when applied to what is currently going on in ominous threats of bioterrorism. Naturally, there friend and colleague Melvin Sanicas, calls
biomedical research. Biology has come a long, are also concerns about the lack of checks and scientists to action in his article on p. 22.
long way since the start of the human genome balances and ethical considerations.1
project. Last year, an infant with a rare disease Medical entomology
was admitted, diagnosed, treated, and discharged Vaccines and viral Because of the recent outbreaks of mosquito-
within 36 hours – after his whole genome was misinformation bourne diseases such as dengue, malaria, Zika,
sequenced in record time of 19.5 hours.2 Vaccines are not new. Till a few years ago, it was and chikungunya infections, the field of medical
Let’s take a look at some of the cutting-edge such a low-profile therapeutic area as the burden entomology has reemerged.9 Here, too, is
research coming out of the omic realm, topics of many infectious diseases have declined to the synthetic biology active, with gene-editing
that some of us may already be writing about. brink of eradication. In recent months however, techniques being explored to control, even wipe

6 | September 2019 Medical Writing | Volume 28 Number 3

 Billiones – Omics in silico and other trends in biomedical research

out disease-carrying species of mosquito without combine the best of both worlds. The EMA, A digital pill
harming the benign types.3 which traditionally only deals with medicinal This product comprises a pill with an embedded
The recently released book How Mosquitoes products, recently released a draft guideline on silicon chip, a wearable sensor, and an App. The
Changed Everything by Brooke Jarvis describes the quality requirements for drug-device chip, once in the stomach, is released and sends
how mosquito-bourne diseases changed the combination products.10 The term combination a signal captured by sensor and recorded in the
course of human history. products brings to mind pre-filled syringes and App. This way, treatment adherence to the
anti-histamine pens. But the trend is towards antipsychotic drug aripiprazole can be moni-
Combination health products: more complex and ingenuous combinations and tored. It was approved by the FDA in 2018.11
ingestible and wearable delivery systems, some examples of which are
devices described below. We writers need to step away Ingestible delivery system
The delineation between drugs and medical from our comfort zone to deal with new Insulin without injections? This may become
devices are becoming blurred, again, as biology terminologies that may come from engineering, possible with a self-orienting mm scale applicator
and technology merge to develop products that informatics, and material science. (SOMA) whose needle is made of insulin and its

www.emwa.org Volume 28 Number 3 | Medical Writing September 2019 | 7

Omics in silico and other trends in biomedical research – Billiones

“plunger” controlled by a sugar disc. This latest A recent manuscript analysed long forgotten Watch your language
breakthrough in oral insulin replacement therapy medical research projects that are suddenly Though not necessarily unethical or politically
for diabetes is currently in testing. Insulin is rediscovered, like “sleeping beauties” awakened incorrect, some terms we use in day-to-day
delivered by ingesting the SOMA, which then by a prince. The paper was rejected by a top US clinical research may be inappropriate for use in
delivers insulin directly into the peritoneal wall.12 journal on the grounds of sexualisation by using medical publications. An ISMPP paper lists
a politically incorrect analogy. Alternative examples of common industry jargon that do not
Wearable medications suggested terms are “hibernators” and “awake- belong in a manuscript, mainly because they are
The next generation of wearables might resemble ners”.14 Do you agree? too colloquial or even commercial. Two
a shirt rather than a watch. Swiss scientists are examples on the list that I have encountered
developing smart medical fibres and drug- Mind your sources frequently are “key opinion leader” (suggestive
releasing textiles. The technology has a wide Even if you mind your metaphors, what about of influence and bias, use “external medical
range of potential applications, from wound care scientifically valid yet ethically questionable expert” or “subject matter expert” instead) and
to glucose monitoring.13 sources? During an operation, a surgeon had to “key messages” (messaging is a commercial term,
refer to the Pernkopf Topographic Anatomy of consider “scientific communication points”
Ethics and political correctness Man to finish a rather tricky emergency pro- instead).16
Let’s have a look at trends in ethical questions cedure. Apparently, no other medical source, The 11th edition of the AMA Manual of Style
and political correctness that can affect the way paper or digital, can match the accuracy and is planned for release this year and will include
we write. spectacularly detailed illustrations of human guidance on terminologies. Here are a few terms:
anatomy in this ≈80-year old volume. It was use of “low income” instead of “poor”; addition
Political (over)correctness? compiled in an Austrian medical school during of LGBTQ as an abbreviation; removal of “CD-
Gender parity and the “me too” movement were the Nazi era, and was based largely on the bodies ROM” and “fax” from the glossary, but inclusion
big topics in 2018 that have impacted our of the victims of those dark times.15 Is it ethically of “cloud” and “IP address”. Furthermore,
behaviours. It follows that sensitivity to these correct to use the material? Is it allowable to cite “sequence variation” and “allelic variant” are
issues is also expected in scientific commu- such materials in scientific papers? Does the end preferred over “mutation” and “polymorphism”,
nication. Yet, we do not have clear guidelines on justify the means? respectively, according to the recommendations
political correctness and cultural sensitivity. of the Human Genome Variation Society.17

8 | September 2019 Medical Writing | Volume 28 Number 3

 Billiones – Omics in silico and other trends in biomedical research

All things planetary Table 1. Glossary of terms

Ever heard of the term “planetary medicine” or
“planetary health”?18 Previously viewed with Term Definition
scepticism, it is now scientifically recognised, Omics a neologism for the constellation of an organism’s “omic” information,
even considered vogue. Check out the call for which includes the genome itself (genomic), transcription products
medical practitioners to act for planetary health (transcriptomic), protein products (proteomic) and metabolic products
and sustainable healthcare in the Lancet.19 (metabolomic).1
In fact, with climate change coming to the
forefront, several subdisciplines of planetary Synthetic biology an interdisciplinary branch of biology and engineering that combines
health have arisen, including planetary various disciplines from within these domains, such as biotechnology,
paediatrics,20 planetary epidemiology,21 and evolutionary biology, molecular biology, systems biology, biophysics,
planetary preventive medicine.22 Here too, computer engineering, and genetic engineering. (Wikipedia)
synthetic biology is being harnessed to address
environmental issues.3 CRISPR/Cas9 stands for ‘Clustered Regularly Interspaced Short Palindromic Repeats’
and it is part of the defence mechanism found in the immune system of
What about digital health? bacteria against viruses. After its discovery, it was used as part of the
We cannot discuss healthcare trends without CRISP/Cas9 genome editing technology, which allows scientists to edit,
mentioning digital health and there is lots of cut, or replace DNA at precise locations. This technology can be applied to
ground to cover, including artificial intelligence permanently modify genes in living cells and organisms with the aim to
and health data from “prewomb to tomb”.24 correct mutations and treat disease.1
As seen in the trends already discussed above,
biology, healthcare, and technology are all in silico an expression used to mean “performed on computer or via computer
interlinked. simulation”. The phrase was coined in 1989 as an allusion to the Latin
I will not focus on this topic here but will phrases in vivo, in vitro, and in situ, which are commonly used in biology
instead let the next issues of Medical Writing – for and refer to experiments done in living organisms, outside of living
December 2019 on digital health, followed by organisms, and where they are found in nature, respectively (Wikipedia).
the issue on Data Economy in 2020 – do justice
to these highly important trends. For now, check DIYbio Do-It-Yourself Biology, a citizen science driven movement that aims to
out and enjoy Eric Topol’s Deep Medicine: How find innovative solutions by studying life sciences related topics in non-
Artificial Can Make Medicine More Humane.24 traditional academic and industrial settings, namely in self-made
It’s medical communication at its best. laboratories (e.g. assembled in kitchens and garages) that are not ruled by
the policies of a research or academic institution.1
Disclaimers
The opinions expressed in this article are the Vaccine hesitancy refers to delay in acceptance or refusal of vaccines despite availability of
author’s own and not necessarily shared by her vaccination services; currently a complex global problem that requires
employers or EMWA. ongoing monitoring (WHO)

Conflicts of interest Drug-device therapeutic and diagnostic products that combine drugs, devices, and/or
Raquel Billiones is an employee of a pharma- combination products biological products (US FDA)
ceutical company.
Medical entomology also known as public health entomology, is focused upon insects and
arthropods that affect human health as disease vectors (Wikipedia)

Planetary medicine body of research that investigates the links between Earth’s natural systems
or planetary health and human well-being, looking at how climate change and resource
depletion cause problems like infectious disease and malnutrition;16.
not to be confused with the term “environmental medicine”, a field that is
dealing with environmental excitants in the surroundings, and not
recognised as a legitimate specialty but rather more of a quackery.23

www.emwa.org Volume 28 Number 3 | Medical Writing September 2019 | 9

Omics in silico and other trends in biomedical research – Billiones

References S,Bitam I, Davoust B, Raoult D, Parola P. 2019v34n1_new_amavstyle.pdf.

1. Rojas CR, Pereira JR, Rosa P. Social, legal Medical entomology: A reemerging field of 18. Irfan U. Planetary medicine needed to deal
and ethical aspects of human genomics. research to better understand vector-borne with global warming. [Cited 2019 June 11].
European Commission Joint Research infectious diseases. Clin Infect Dis. 2017 Available from:
Centre Technical Report. 2019 [cited 2019 Aug 15;65(suppl_1):S30–8. https://www.scientificamerican.com/
June 11]. Available from: 10. European Medicines Agency. Consultation article/planetary-medicine-needed-to-deal-
http://publications.jrc.ec.europa.eu/ on draft guideline on quality requirements with-global-warming/.
repository/bitstream/JRC114681/report_ for medical devices in combination 19. Veidis EM, Myers SS, Almada AA, Golden
genomicsvonline.pdf. products. 2019 [cited 2019 June 11]. CD; Clinicians for Planetary Health
2. New GUINNESS WORLD RECORDS™ Available from: https://www.ema. Working Group. A call for clinicians to act
title set for fastest genetic diagnosis. 2018 europa.eu/en/news/consultation-draft- on planetary health. Lancet.
[cited 2019 June 11]. Available from: guideline-quality-requirements-medical- 2019;393(10185):2021.
https://www.rchsd.org/about- devices-combination-products. 20. Goldhagen J. Planetary Pediatrics. Acad
us/newsroom/press-releases/new- 11. Emspak J. FDA approves first ‘digital’ pill: Pediatr. 2019 Apr 26. pii:S1876-
guinness-world-records-title-set-for-fastest- How does it work? 2017 [cited 2019 June 2859(19)30125-1.
genetic-diagnosis/. 11]. Available from: 21. Butler CD. Planetary epidemiology:
3. The promise and perils of synthetic biology. https://www.livescience.com/60963-how- Towards first principles. Curr Environ
2019 [cited 2019 June 11]. Available from: does-digital-pill-work-abilify.html. Health Rep. 2018;5(4):418—29.
https://www.economist.com/leaders/ 12. Bridger H. Microneedle pill takes the sting 22. Prescott SL, Logan AC, Katz DL.
2019/04/04/the-promise-and-perils-of- out of insulin. 2019 [cited 2019 June 11]. Preventive medicine for person, place, and
synthetic-biology. Available from: https://news.harvard.edu/ planet: Revisiting the concept of high-level
4. Morton O. The engineering of living gazette/story/2019/02/microneedle-pill- wellness in the planetary health paradigm.
organisms could soon start changing takes-the-sting-out-of-insulin/. Int J Environ Res Public Health.
everything. [cited 2019 June 11]. Available 13. Six A. Medication you can wear. 2018 2019;16(2):E238.
from: https://www.economist.com/ [cited 2019 July 10]. Available from: 23. Hall H. Environmental medicine – Not
technology-quarterly/2019/04/04/the- https://www.empa.ch/web/s604/ your average specialty. [Cited 2019 June
engineering-of-living-organisms-could- medication-you-can-wear. 11]. Available from:
soon-start-changing-everything The 14. Buffy D. Scientific journal snubs academic https://sciencebasedmedicine.org/
Economist 4 Apr 2019. over Sleeping Beauty metaphor. 2019 environmental-medicine/.
5. Bergamin F. First bacterial genome created [cited 2019 June 11]. Available from: 24. Topol E. Deep medicine: How artificial
entirely with a computer. 2019 [cited 2019 https://www.theguardian.com/science/ intelligence can make medicine more
June 11]. Available from: 2019/apr/26/scientific-journal-snubs- humane. New York: Basic Books; 2019.
https://www.ethz.ch/en/news-and- academic-over-sleeping-beauty-metaphor.
events/eth-news/news/2019/03/ 15. Begley S. The surgeon had a dilemma only a
bacterial-genome-created-with- Nazi medical text could resolve. Was it
computer.html. ethical to use it? 2019 [cited 2019 June 11].
6. Larson H. The biggest pandemic risk? Viral Available from: http://bioethicsbulletin.
misinformation. Nature. 562(7727):309. org/archive/the-surgeon-had-a-dilemma-
7. World Health Organization. Q&A on the only-a-nazi-medical-text-could-resolve.
malaria vaccine implementation 16. Gonzales J, Petruzzi P. Mind your language:
programme (MVIP). [cited 2019 June 11]. Considerations for medical publication Author information
Available from: https://www.who.int/ professionals. ISMPP Newsletter 2019. Raquel Billiones, PhD, has been a regulatory
malaria/media/malaria-vaccine- [cited 2019 June 11]. Available from: medical writer for more than 13 years and is
implementation-qa/en/. https://ismpp-newsletter.com/2019/02/ currently Head of Medical Writing at Takeda
8. Murray A. The rebel alliance against 13/mind-your-language-considerations- Vaccines in Zurich, Switzerland. Previously,
antiscience. [cited 2019 June 11]. Available for-medical- publication-professionals/. she headed a medical writing team in a global
from: https://andrewmurraywriter. 17. Walden LA. What’s new in the AMA clinical research organisation, working on
wixsite.com/books/rebel-alliance-against- Manual of Style. AMWA J. 2019;34. 2019 both pharma and medical devices. She is an
antiscience. [cited 2019 July 10]. Available from associate editor of Medical Writing and an
9. Laroche M, Bérenger JM, Delaunay P, https://cdn.ymaws.com/www.amwa.org/ EMWA workshop leader.
Charrel R, Pradines B, Berger F, Ranque resource/resmgr/journal/spotlight/

10 | September 2019 Medical Writing | Volume 28 Number 3

New recommendations released:
Good Practice for Conference Abstracts
and Presentations
Research that has been sponsored by pharm- further, before submitting for publication. References
aceutical, medical device, and biotechnology The recommendations cover the following: 1. Battisti WP, Wager E, Baltzer L, et al. Good
companies is often presented at scientific and l authorship and contributorship Publication Practice for Communicating
medical conferences. Although there is an l transparency Company-Sponsored Medical Research:
industry standard to guide the development of l development, review, and approval of GPP3. Ann Intern Med. 2015;163:461–4.
full publications (Good Publication Practice for abstracts and presentations 2. Foster C, Wager E, Marchington J, et al.
Industry Sponsored Research, GPP3),1 this only l guidance on re-presentation of data (encore Good Practice for Conference Abstracts and
touches on conference presentations. Until now, abstracts) Presentations: GPCAP. Res Integr Peer Rev.
no specific guidelines or recommendations have l copyright considerations 2019;4:11.
been available to adequately describe best l appropriate citation of conference presentations 3. Foster C, Wager E, Marchington J, et al.
practice for conference presentations. Good Practice for Conference Abstracts and
The Good Practice for Conference Abstracts While developed with pharmaceutical industry Presentations: GP-CAP. PeerJ Preprints.
and Presentations (GPCAP) recommenda- sponsored research in mind, we believe that these 2017;5:e3356v1.
tions2 address the specific challenges of recommendations are applicable to all research
developing abstracts and presentations for submitted to conferences, and we encourage
academic conferences. The authors are all readers from other fields to offer suggestions for
experienced publication professionals, having further development via our website
worked for either medical communications (http://gpcap.org).
agencies or pharmaceutical companies, who By following GPCAP recommendations, Good Practice for Conference Abstracts and
have encountered the practical challenges industry professionals, authors, and conference Presentations was developed by Cate Foster
associated with conference presentations. organisers will improve consistency, trans- ™
(MA, ISMPP CMPP ), Liz Wager (PhD),
Having drafted an initial framework, the draft
recommendations were published as a preprint
parency, and integrity of publications submitted
to conferences worldwide.
Jackie Marchington (PhD, ISMPP CMPP ), ™
Mina Patel (PhD), Steve Banner (PhD, MA),
at PeerJ3 for public review and comment to Nina C Kennard (ISMPP CMPP ), and ™
gain broader feedback, which enabled
the authors to refine the recommendations
Cate Foster
[email protected]
Rianne Stacey (PhD, ISMPP CMPP ). ™

www.emwa.org Volume 28 Number 3 | Medical Writing September 2019 | 11

 Catching the wave of lifestyle medicine
Maria Carolina Rojido complex interactions between these processes
massive research, educational, and medical
Freelance Medical Writer, Ségoufielle, France result in effects different from those that might
communication needs for all audiences, from
be expected. In other words, the whole is greater
laypersons to experts. Interested medical
than the sum of its parts.1
writers may have abundant opportunities to
Correspondence to: work on this rising medical specialty in the
Non-communicable diseases (NCDs) are
Maria Carolina Rojido good examples of this. Together, they cause 86%
near future.
1078 Chemin Bordeneuve of all deaths in Europe2 and 70% globally.3 They
Ségoufielle, France, 32600 include cardiovascular disease, chronic neuro-
+33 6 48 72 06 18 Fertile ground for a new trend logic disorders (e.g., dementia), chronic respi-
[email protected] Modern medicine and the reductionist ratory diseases, diabetes, cancer, musculoskeletal
approach diseases, and autoimmune disorders. Their
Medicine is complex and is continuously prevalence and incidence are growing, and most
Abstract evolving. Through history it has gone through are not curable or reversible by traditional means.
Non-communicable diseases (degenerative several paradigms that have dominated the way These NCDs are the result of a combination of
chronic diseases) are wreaking havoc on healers thought about diseases and how to cure genetic, physiologic, environmental, and be-
human health, causing 70% of deaths world- them. At present, modern medicine follows a havioural factors that are very often shared
wide, but lifestyle medicine is ready to tackle mostly reductionist paradigm. This ‘divide and between them. Their aetiologies, pathophysio-
them by helping people change the habits conquer’ approach, where processes are reduced logies, and treatments are well known, but they
behind them. A new medical specialty, into simpler units to understand them, has are still the world’s biggest killers. Why? It may
lifestyle medicine can help relieve strained allowed for amazing advances in diagnosing, be because, although we know them well, we do
healthcare systems globally and is backed by treating, and preventing diseases. It is possible to not understand them completely. We use reduc-
a solid body of evidence. Moreover, there are explore biological processes underlying a disease tionism to understand them since they are so
at the molecular level, but sometimes the complex, but we underestimate their root causes

12 | September 2019 Medical Writing | Volume 28 Number 3

 Rojido – Catching the wave of lifestyle medicine

and are fed by companies that do not care about 50% of the disease burden in lower-middle
health. The problem starts in medical school, income countries and affecting more younger
where education on nutrition, exercise, addictive people than in wealthier countries.13 This
substance avoidance, and other lifestyle inter- negatively impacts the economies of lower-
ventions is notoriously deficient. As a con- middle income countries. Meanwhile, NCDs
sequence, physicians who recommend lifestyle cause 77% of the disease burden in Europe.2 And
changes as a first line of prevention and disease although premature mortality from NCDs has
management may feel unprepared to provide decreased, there is a significant gap between life
counselling in behavioural changes.7 To make expectancy and healthy life expectancy (the
matters worse, the companies that sell animal number of years that a person is expected to live
products and ultra-processed foods (e.g. pack- without an activity limitation or disability),14
aged baked foods, fizzy drinks, sugary cereals, with men spending a fifth of their life in poor
ready meals, reconstituted meat products) are health and women nearly a quarter.15
more interested in their profits than in the The above changes have all happened at an
healthiness of their offerings.1 unprecedented pace that never seems to wane,
as NCDs reach pandemic proportions and
Human lifestyle changes and diseases disproportionally affect disadvantaged popu-
Homo sapiens appeared about 315,000 years ago.8 lations that do not have proper access to
In the last 10,000 years, our lifestyle habits have treatment.13
changed considerably. Our diet has seen some of
the biggest changes. The advent of dairy prod- The “new” trend of lifestyle
ucts, refined plant derivatives (cereals, sugars, medicine
vegetable oils), fatty meats, and salt critically and What is it?
fundamentally altered the glycaemic load, macro- Lifestyle changes have been a part of healthcare
nutrient content, fatty acid composition, micro- recommendations for decades, but they have
nutrient density, acid-base balance, sodium- traditionally only been considered helpful
potassium ratio, and fibre content of our diet.9 measures and are often still considered optional.
Moreover, recent studies have linked ultra- First mentioned as a medical discipline in 1999,16
processed foods with weight gain and cancer. 10,11 lifestyle medicine is the logical response to our
This shift, plus other changes like an increasingly chronic disease pandemic. The Lifestyle Medicine
and how they interact with each other. Also, sedentary lifestyle, chronically inadequate sleep, Global Alliance (an organisation that unites
although medicine offers fairly effective treat- high stress, and use of addictive sub- national lifestyle medicine professional
ments for many of them, it does not properly stances (tobacco, alcohol, other Non- associations from around the world
address their risk factors: the reasons why people drugs), are very recent relative to communicable under a single banner) defines it
get these diseases in the first place are most often our evolutionary history and diseases (NCDs) are as “the evidence-based medical
environmental and behavioural factors which underlie many of our degen- specialty that uses lifestyle
affect physiological processes and gene expres- erative chronic diseases. Such
good examples of this. therapeutic approaches, such
sion, among other things.4 Studies showing diseases are rarer in popula- Together, they cause as a predominantly whole food
dramatically increased rates of cardiovascular tions that have not much 86% of all deaths in plant-based diet, regular physical
disease and cancers of people migrating from changed their traditional life- Europe and 70% activity, adequate sleep, stress
low-risk to high-risk countries have shown that styles. The most notable examples management, avoidance of risky
environmental/behavioural factors are the of these are the inhabitants of the ‘blue
globally. substance use, and other non-drug
primary determinants of chronic diseases, not zones’: five places in the world that “not only modalities, to prevent, treat, and, oftentimes,
genetic ones.5 And other studies, including twin have high concentrations of individuals over 100 reverse non-communicable disease, sometimes
studies, have shown that only 10 to 30% of years old, but also clusters of people who had referred to as degenerative chronic disease.”17
chronic diseases are due to genetic factors.6 grown old without health problems like heart Lifestyle medicine uses a thoroughly holistic
It is far easier for healthcare professionals to disease, obesity, cancer, or diabetes”.12 approach, where whole plant-based foods work
prescribe drugs or recommend surgery and for In the last century, there have been gains in synergistically and, together with exercise, stress
patients to accept these often expensive and risky the fight against communicable diseases and reduction, sleep, harmful substance avoidance,
treatments than to change lifelong habits child and maternal mortality, but they are still and social support, help the whole person (body,
reinforced by a consumerist society. This is not major problems in developing countries. At the mind, and microbiome). Prolonged healthy life
helped by the fact that we are cared for by same time, rates of NCDs increased by almost expectancy allows individuals to be more
physicians who do not fully understand nutrition 30% between 2000 and 2015, causing more than productive in their professional and personal

www.emwa.org Volume 28 Number 3 | Medical Writing September 2019 | 13

Catching the wave of lifestyle medicine – Rojido

lives. These changes can also help societies thrive artificial ingredients). It differs from veganism in to lifestyle medicine have greatly increased in
by reducing their overall disease burden and its emphasis on whole foods; despite their number in the last 30 years. In Clinicaltrials.gov,
healthcare costs. Last but not least, they are deleterious health effects,10,11 highly processed studies with the words lifestyle (factors, changes,
aligned with the changes humanity needs to plant foods are accepted in veganism. It also interventions), plant-based (diet, dietary, or
implement for the sustainability of life on differs in that it encompasses a spectrum of eating food), sleep, exercise (or physical activity), and
our planet, including our own as a species patterns that are predominantly plant-based but stress management under the search field Other
(Figure 1).18 that, like vegetarianism, may include some animal Terms increased on average 25-fold between
products. However, its therapeutic effects appear 1990–1999 and 2000–2009 and 4-fold between
Key elements? to be more significant the closer it is to 100% 2000–2009 and 2010–2019 (Table 1). By com-
Lifestyle medicine uses lifestyle interventions plant-based.20–23 parison, oncology studies increased on average
involving behavioural, environmental, medical Together with other lifestyle interventions, 8-fold between 1990-1999 and 2000-2009 and
and motivational principles to prevent, treat, and this diet is anti-inflammatory, modifies gene 2-fold between 2000-2009 and 2010-2019
sometimes reverse NCDs that share risk factors expression, and changes our microbiome, (Figure 2).
and underlying mechanisms. It is complementary thereby helping reverse the chemical processes In terms of individual studies, the Nurses’
to traditional medicine, acting as an adjuvant to behind NCDs.4 Health Study (in which 75,521 women aged 38
clinical and surgical interventions.19 It is low cost to 63 years old were followed for 10 years)
and causes few, if any, side effects. The growing body of evidence concluded that more than 80% of all heart disease
The central element is a whole food plant- The modern Western lifestyle is responsible for and more than 91% of all diabetes in women
based diet that emphasises the consumption of the global increase in NCD burden. Changing could be eliminated if they were to adopt a cluster
minimally processed and nutrient-dense veg- that lifestyle could help prevent, treat, and even of positive practices (keeping a healthy body
etables, fruits, whole grains, legumes, nuts, and reverse most NCDs: eliminating NCD risk weight, regular physical activity, avoiding tobacco
seeds. It minimises or eliminates meat, poultry, factors can prevent 75% of heart disease, stroke, products, consuming more whole grains, fruit,
fish, eggs, dairy products, and processed foods of and type 2 diabetes and 40% of cancer.24 and vegetables, and consuming no more than one
animal (sausages and cured meats) or plant origin The body of evidence supporting lifestyle alcoholic beverage per day).25 The US Health
(refined grains, added refined sugars and oils, interventions is growing. Research studies related Professionals Study26 (in which 42,847 men aged

Lifestyle Medicine

Physical
Activity

Stress Traditional
Management Sleep Medicine
WFPB
Diet

Social Harmful
Support Substance
Avoidance

Whole person: Body, Mind and Microbiome

Whole Society : Economy

Whole Planet : Sustainability

Figure 1. How lifestyle medicine works, according to the author

14 | September 2019 Medical Writing | Volume 28 Number 3

 Rojido – Catching the wave of lifestyle medicine

40 to 75 years old were followed up for 16 years) 13 human malignancies to excess body fat.27 In spite of these findings, the well-known
found similar results in men. Elsewhere, the Smaller studies have shown that a whole food statement “more research is needed” could not be
American Institute for Cancer Research and the plant-based diet can help treat and reverse more relevant than when it comes to studies
International Agency for Research on Cancer cardiovascular disease and diabetes, and that it looking at the effects of whole food plant-based
concluded that there is sufficient evidence to link can help treat cancers.20,21,23,28,29,30 nutrition. Most of the research has been done

Table 1. ClinicalTrials.gov search for studies related to lifestyle medicine with start dates from January 1, 1990, to June 25, 2019.

The keywords used under the search field “Other Terms” were:
1. “lifestyle factors OR lifestyle changes OR lifestyle interventions” (plus the synonyms “interventional” and “procedures”)
2. “plant-based diet OR plant-based dietary OR plant-based food”
3. “sleep”
4. “exercise” (plus the synonym “physical activity”)
5. “stress management”

Search term(s) January 1, January 1, Fold increase January 1, Fold increase

1990 – 2000 – (2000–2009 2010 – (2010–2019
December 31, December 31, vs. 1990- June 25, vs. 2000 –
1999 2009 1999) 2019 2009)
1. Lifestyle (factors, changes, interventions) 43 829 19 2849 3
2. Plant-based (diet, dietary, food) 0 16 16 106 7
3. Sleep 75 2702 36 8598 3
4. Exercise/physical activity 172 4138 24 16,890 4
5. Stress management 11 324 29 1172 4
Sum (1 to 5) 301 8009 27 29,615 4
Average (1 to 5) 25 4
Oncology (cancer, tumor, neoplasm) 2725 21,923 8 42,536 2
All studies registered 6443 88,478 14 194,696 2

For comparison, “oncology” (plus the synonyms “neoplasm’, “cancer”, “tumor”, “malignancy”, “neoplasia”, “neoplastic syndrome”, “oncologic”, and “neoplastic disease”) was searched for
under the search field “Conditions or disease”. Each set of keywords was searched three times for the periods January 1, 1990, to December 31, 1999; January 1, 2000, to December 31,
2009; and January 1, 2010, to June 25, 2019. All study types and results were included.

40 36
35
29
30
Fold increase

24
25
19
20
16
15
10 8 7
5 3 3 4 4
2
0
2000-2009 vs. 1990-1999 2010-2019 vs. 2000-2009

n Lifestyle (factors, changes, interventions) n Exercise/Physical Activity

n Plant-based (diet, dietary, food) n Stress management
n Sleep n Oncology (cancer, tumor, neoplasm)

Figure 2. Fold increases in studies listed in ClinicalTrials.gov related to lifestyle medicine from 1990–1999 to 2000–2009
and from 2000–2009 to 2010–2019. Oncology studies are included for reference.

www.emwa.org Volume 28 Number 3 | Medical Writing September 2019 | 15

Catching the wave of lifestyle medicine – Rojido

under the reductionist paradigm, looking at the studies, but much more research is still needed. incorporate more education on nutrition and
effects of single foods or components. lifestyle medicine, because their current
Fortunately, the effects of dietary and other Where is it going? curriculums are deficient in these aspects and
lifestyle interventions are increasingly being Education and training medical students are demanding it. Harvard
studied, even in the context of randomised Many medical universities are starting to Medical School incorporated a Division of

Table 2. PubMed search for articles related to lifestyle medicine with publication dates from January 1, 1990, to June 25, 2019.

Titles were searched for the following keywords:

1. “lifestyle interventions OR lifestyle factors OR lifestyle changes”
2. “plant-based diet OR plant-based dietary OR plant-based food”
3. “sleep”
4. “exercise OR physical activity”
5. “stress management”
6. “oncology OR cancer OR tumor OR neoplasm OR malignancy”.

Search term(s) January 1, January 1, Fold increase January 1, Fold increase

1990 – 2000 – (2000–2009 2010 – (2010–2019
December 31, December 31, vs. 1990- June 25, vs. 2000–
1999 2009 1999) 2019 2009)
1. Lifestyle (factors, changes, interventions) 213 1006 5 2382 2
2. Plant-based (diet, dietary, food) 3 30 10 134 4
3. Sleep 10,269 19,453 2 40,062 2
4. Exercise/physical activity 18,261 31,310 2 64,917 2
5. Stress management 285 526 2 917 2
Sum (1 to 5) 29,031 52,325 2 108,412 2
Average (1 to 5) 4 3
Oncology (cancer, tumor, neoplasm, malignancy) 147,014 281,357 2 564,168 2

Each of these sets of keywords was searched three times, for the periods January 1, 1990, to December 31, 1999; January 1, 2000, to December 31, 2009; and January 1, 2010, to June 25,
2019, by adding the following to the search string: AND ((“1990/01/01”[PDat] : “1999/12/31”[PDat])), AND ((“2000/01/01”[PDat] : “2009/12/31”[PDat])), AND
((“2010/01/01”[PDat] : “2019/06/25”[PDat])). No other filters were applied.

12
10
10
Fold increase

6 5
4
4
2 2 2 2 2 2 2 2 2
2

0
2000-2009 vs. 1990-1999 2010-2019 vs. 2000-2009
n Lifestyle (factors, changes, interventions) n Exercise/Physical Activity
n Plant-based (diet, dietary, food) n Stress management
n Sleep n Oncology (cancer, tumor, neoplasm)

Figure 3. Fold increases in articles published in PubMed related to lifestyle medicine from 1990–1999 to 2000–2009
and from 2000–2009 to 2010–2019. Oncology studies are included for reference.

16 | September 2019 Medical Writing | Volume 28 Number 3

 Rojido – Catching the wave of lifestyle medicine

Nutrition in 1996,31 and a residence programme recommending a plant-based diet.36 American Cancer Society, the American
is currently being piloted in four American Following the lead of Kaiser Permanente, a Diabetes Association, and the American
universities.32 In Europe, Cambridge University large managed care organisation in the US that Heart Association emphasises the benefits of
is creating a new curriculum on public health advises its physicians to recommend an active whole‐grain foods, legumes, vegetables, and
with a focus on nutrition, physical activity, and lifestyle and plant-based diet to their patients, fruits and recommends limitations on red
sleep,33 and the UK University of Surrey offers a lifestyle counselling is starting to be reimbursed meat, full‐fat dairy products, and items high
Masters in Nutritional Medicine. in the US.37 in added sugars.42
Many medical organisations offer national Moreover, lifestyle medicine is increasingly being
and international board certification prog- The evidence translates into… addressed by major medical journals. The Lancet
rammes. Several lifestyle medical associations are Similar to the ClinicalTrials.gov study trends established the ‘Food in the Anthropocene’
supporting licensed physicians wanting to train mentioned above, numbers of PubMed articles commission, a scientific consensus of what
themselves on lifestyle medicine. The first was with the words lifestyle (factors, changes, and constitutes a healthy and sustainable diet and the
the American College of Lifestyle Medicine, interventions), plant-based (diet, dietary, or actions needed to support the accelerated
which founded the Lifestyle Medicine Global food), sleep, exercise (or physical activity), and transformation of our food system for the sake of
Alliance in 2015 “in response to the need for stress management in their titles have increased our health and our planet,18 and launched The
lifestyle solutions in low- and middle-income greatly. A simple search of the number of articles Lancet Planetary Health open access journal in
countries and for coordination between lifestyle for the periods 1990–1999, 2000–2009, and April 2017. BMJ Nutrition, Prevention and Health,
medical professional organisations around the from 2010 to June 25, 2019, shows the trend. which launched in July 2018, publishes on the
world”. It includes organisations based in the Studies related to lifestyle topics increased on impact of nutrition and lifestyle factors on
United States, Australasia, the United Kingdom, average fourfold between 1990–1999 and 2000– individual and population health. Other note-
Lithuania, Albania, Portugal, Iran, and Korea.17 2009 and threefold between 2000–2009 and worthy journals dedicated to the subject are the
Other lifestyle medicine associations and 2010–2019 (Table 2). By comparison, oncology American Journal of Lifestyle Medicine and the
organisations include the European Lifestyle studies increased on average twofold between International Journal of Disease Reversal and
Medicine Organization, the Institute of Lifestyle 1990–1999 and 2000–2009 and between 2000– Prevention. Congresses and conferences on
Medicine, and the Plantrician Project. 2009 and 2010–2019 (Figure 3). lifestyle medicine and whole food plant-based
The increased number of publications has nutrition are also increasing in number and
Funding and policy changes translated into new and clearer guidelines and attendance.
Calls for grants related to lifestyle medicine are recommendations in terms of what measures
abundant. The NIH’s National Center for Com- should be put in effect (or not): Relevance to medical writers
plementary and Integrative Health is requesting l The 2017 ACC/AHA/AAPA/ABC/ACPM/ Even if lifestyle medicine were to become a global
grant applications, as is the European Com- AGS/APhA/ASH/ASPC/NMA/PCNA phenomenon, people would still get sick and
mission’s Steering Group on Health Promotion, Guideline for the Prevention, Detection, need drugs or surgery for acute and chronic life-
Disease Prevention, and Management of Evaluation and Management of High threatening conditions. However, the effec-
NCDs.34 The American College of Lifestyle Blood Pressure in Adults rec- tiveness of traditional medicines can
Medicine and many other foundations (such as ommends the plant-based be greatly increased if lifestyle
Even if lifestyle
the Ardmore Institute of Health, the Weil DASH (Dietary Approaches changes are encouraged as a
Foundation, and the Osher Center for Integrative to Stop Hypertension) diet medicine were to become real part of prevention and
Medicine) and organisations (such as ProVeg, an as one of the basic steps to a global phenomenon, treatment. Healthcare sys-
international food awareness organisation that fight hypertension. 38 tems are collapsing under
people would still get sick
aims to improve human health, animal welfare, l The World Cancer Re- the weight of NCDs and
and need drugs or surgery
the environment, food justice, and public opinion search Fund recommen- developing countries’ econ-
on plant-based food) offer grants as well. dations regarding lifestyle for acute and chronic omies are failing in part due
Policy changes are starting to take place, as changes for preventing and life-threatening to the double burden of
hospitals and schools add more plant-based surviving cancer include basic conditions. diseases (communicable and non-
options and businesses (e.g. Nestlé, Danone, concepts underpinning whole food communicable) and lack of resources
Unilever, Cargill) try to improve the quality and plant-based diets.39,40 they suffer.
sustainability of their offerings.35 Earlier this l The 2013 AHA/ACC/TOS Guideline for the The body of evidence behind lifestyle
year, the Canadian government changed its Management of Overweight and Obesity in medicine is now so large that it comes down to
dietary recommendations by eliminating the Adults includes plant-based diets in its honouring the Hippocratic oath and its most
dairy section to simply encouraging people to recommended strategies to achieve caloric essential “First do no harm” concept. Many
consume 50% vegetables and fruit, 25% whole deficits.41 medical writers are healthcare professionals of
grains, and 25% protein foods (meats, dairy, l Preventing Cancer, Cardiovascular Disease some kind, and healthcare professionals have an
beans, nuts, or seeds). That is, it is now and Diabetes: A Common Agenda for the ethical duty to inform their patients about the

www.emwa.org Volume 28 Number 3 | Medical Writing September 2019 | 17

Catching the wave of lifestyle medicine – Rojido

lifestyle and dietary changes that can help them Conflicts of interest human-evolution.
avoid suffering, disability, and early death. Some The author declares no conflicts of interest. 9. Cordain L, Eaton SB, Sebastian A, et al.
might say that medical writers are not qualified Origins and evolution of the Western diet:
to give such advice. But we know smoking makes References health implications for the 21st century.
people sick, so all types of physicians have a duty 1. Campbell TC. The China study: the most Am J Clin Nutr. 2005;81(2):341–54.
to tell smokers to stop. If food can literally be the comprehensive study of nutrition ever 10. Fiolet T, Srour B, Sellem L, et al.
poison or the medicine people take every time conducted and the startling implications Consumption of ultra-processed foods and
they eat or drink, why not say so? Recom- for diet, weight loss and long-term health. cancer risk: results from NutriNet-Sante
mendations should not be watered down under Campbell TM, editor. Kent Town, S. Aust: prospective cohort. BMJ. 2018;360:k322.
the assumption that people will not change their Wakefield Press; 2007. 11. Hall KD, Ayuketah A, Brychta R, et al.
habits. Other lifestyle changes are clearly very 2. World Health Organization. European Ultra-processed diets cause excess calorie
important, and depending on socioeconomic Office for NCDs. 2019 [cited 2019 May intake and weight gain: An inpatient
circumstances they may be harder or easier to 30]. Available from: http://www.euro.who. randomized controlled trial of ad libitum
implement. But one thing we are sure of: int/en/health-topics/noncommunicable- food intake. Cell Metab. 2019;30(1):67–
everybody eats and drinks many times a day, and diseases. 77.e3.
most of us have at least some say over what we 3. World Health Organization. Non- 12. National Geographic. 5 “blue zones” where
consume. We can be sure we’ll all die someday, communicable diseases. 2018 [cited 2019 the world’s healthiest people live. 2017
but what if we can stay healthy longer and die May 30]. Available from: [cited 2019 May 30]. Available from:
much later? https://www.who.int/news-room/fact- https://www.nationalgeographic.com/
Medical writers should be aware of lifestyle sheets/detail/noncommunicable-diseases. books/features/5-blue-zones-where-the-
medicine, as sooner or later they may be asked to 4. Bodai BI, Nakata TE, Wong WT, et al. worlds-healthiest-people-live/.
work on documents related to it. The demand for Lifestyle medicine: A brief review of its 13. The next pandemic? Non-communicable
regulatory documents will rise. But it is medical dramatic impact on health and survival. diseases in developing countries. The
communications that will likely see the most Perm J. 2018;22:17-025. Economist Intelligence Unit Limited. 2017.
activity, because of the huge need to fill 5. Willett WC KJ, Nugent R, et al. In: Jamison 14. Eurostat. Number of healthy years of life:
knowledge gaps at all levels. Perhaps some DT BJ, Measham AR, et al., editors. countries compared. 2019 [cited 2019 July
medical writers will seek opportunities to write Disease control priorities in developing 4]. Available from: https://ec.europa.eu/
on this subject because they are interested in it countries. 2nd ed. Washington (DC): eurostat/web/products-eurostat-news/-
for the benefit of their health or that of the The International Bank for Reconstruction /DDN-20190204–1.
environment. Some of those grants, studies, and Development/The World Bank; 2006. 15. EPHA E, NCDA. Joint paper: Towards an
articles, books, websites, or conferences may 6. Rappaport SM, Smith MT. Epidemiology. EU strategic framework for the prevention
come knocking on our doors sooner than Environment and disease risks. Science. of non-communicable diseases (NCDs).
expected. So, be ready! 2010;330(6003):460–1. Brussels, Belgium: European Public Health
7. Polak R, Pojednic RM, Phillips EM. Alliance, 2019.
Acknowledgements Lifestyle medicine education. Am J 16. Rippe JM, editor. Lifestyle medicine.
The author would like to thank Stephen Gilliver Lifestyle Med. 2015;9(5):361–7. 1st ed. New York: Blackwell; 1999.
for his invaluable expertise and dedication, Laura 8. Tuttle RH. Human evolution: 17. Lifestyle Medicine Global Alliance. About.
Collada Ali for her encouragement and wisdom, Encyclopaedia Britannica; 2019 [cited 2019 [cited 2019 May 31]. Available from:
and Helen Spottiswoode and Julia James for their 2019 July 4]. Available from: https://lifestylemedicineglobal.org/about/.
assistance. https://www.britannica.com/science/ 18. Willett W, Rockstrom J, Loken B, et al.

18 | September 2019 Medical Writing | Volume 28 Number 3

 Rojido – Catching the wave of lifestyle medicine

Food in the Anthropocene: the EAT- Tumor angiogenesis as a target for dietary 37. Jensen LL, Drozek DS, Grega ML, Gobble
Lancet Commission on healthy diets from cancer prevention. J Oncol. J. Lifestyle medicine: Successful
sustainable food systems. Lancet. 2012;2012:879623. reimbursement methods and practice
2019;393:447–92. 30. Liu RH. Health benefits of fruit and models. Am J Lifestyle Med.
19. Sagner M, Katz D, Egger G, et al. Lifestyle vegetables are from additive and synergistic 2019;13(3):246–52.
medicine potential for reversing a world of combinations of phytochemicals. Am J Clin 38. Whelton PK, Carey RM, Aronow WS, et al.
chronic disease epidemics: from cell to Nutr. 2003;78(3):517–20. 2017 ACC/AHA/AAPA/ABC/ACPM/
community. Int J Clin Pract. 31. Harvard Medical School. Division of AGS/APhA/ASH/ASPC/NMA/PCNA
2014;68(11):1289–92. Nutrition. 2018 [cited 2019 June 6]. guideline for the prevention, detection,
20. Ornish D, Scherwitz LW, Billings JH, et al. Available from: evaluation, and management of high blood
Intensive lifestyle changes for reversal of http://nutrition.med.harvard.edu/. pressure in adults: A report of the
coronary heart disease. JAMA. 32. American College of Lifestyle Medicine. American College of Cardiology/American
1998;280(23):2001–7. Education. 2019 [cited 2019 May 31]. Heart Association Task Force on Clinical
21. Ornish D, Weidner G, Fair WR, et al. Available from: Practice Guidelines. Hypertension.
Intensive lifestyle changes may affect the https://www.lifestylemedicine.org/ACLM 2018;71(6):e13-e115.
progression of prostate cancer. J Urol. /Education/ACLM/Education/Education. 39. World Cancer Research Fund. Cancer
2005;174(3):1065–9. aspx?hkey=bec27dc0–9da5–4e38-b7da- prevention recommendations. 2019 [cited
22. Allen KE, Gumber D, Ostfeld RJ. Heart 8b7b090cfd7e. 2019 May 31]. Available from:
failure and a plant-based diet. A case-report 33. Sayburn A. Lifestyle medicine: a new https://www.wcrf.org/dietandcancer/
and literature review. Front Nutr. medical specialty? BMJ (Clinical research cancer-prevention-recommendations.
2019;6:82. ed). 2018;363:k4442. 40. World Cancer Research Fund.
23. Barnard ND, Cohen J, Jenkins DJ, et al. 34. European Commission. Funding and Recommendations during and after cancer.
A low-fat vegan diet and a conventional tender opportunities. 2017 [cited 2019 2019 [cited 2019 May 31]. Available from:
diabetes diet in the treatment of type 2 May 31]. Available from: https://www.wcrf.org/dietandcancer/
diabetes: a randomized, controlled, 74-wk https://ec.europa.eu/info/funding- recommendations/during-after-cancer.
clinical trial. Am J Clin Nutr. tenders/opportunities/portal/screen/ 41. Jensen MD, Ryan DH, Apovian CM, et al.
2009;89(5):1588–96. opportunities/topic-details/pj-01–2017. 2013 AHA/ACC/TOS Guideline for the
24. World Health Organization. Non- 35. Gustafson DI, Edge MS, Griffin TS, Management of Overweight and Obesity in
communicable diseases, Fact file. 2013. Kendall AM, Kass SD. Growing progress in Adults. Circulation. 2014;129(25 Suppl
[cited 2019 May 30]. Available from: the evolving science, business, and policy of 2):S102–38.
http://www.who.int/features/factfiles/ sustainable nutrition. Curr Dev Nutr. 42. Eyre H, Kahn R, Robertson RM.
noncommunicable_diseases/en/. 2019;3(6):nzz059. Preventing cancer, cardiovascular disease,
25. Liu S, Stampfer MJ, Hu FB, et al. Whole- 36. BBC. Is milk healthy? Canada’s new food and diabetes: a common agenda for the
grain consumption and risk of coronary guide says not necessarily. 2019 [cited 2019 American Cancer Society, the American
heart disease: results from the Nurses’ June 30]. Available from: Diabetes Association, and the American
Health Study. Am J Clin Nutr. https://www.bbc.com/news/world-us- Heart Association. CA: Cancer J Clin.
1999;70(3):412–9. canada-46964549. 2004;54(4):190–207.
26. Chiuve SE, McCullough ML, Sacks FM,
Rimm EB. Healthy lifestyle factors in the
primary prevention of coronary heart
disease among men: benefits among users
and nonusers of lipid-lowering and
antihypertensive medications. Circulation.
2006;114(2):160–7.
27. Egger GJ, Binns AF, Rossner SR. The
emergence of “lifestyle medicine” as a
structured approach for management of Author information
chronic disease. Med J Aust. 2009;190 Carolina Rojido is a physician with certification for plant-based
(3):143–5. nutrition and a master’s degree in health administration. She has 7
28. Esselstyn CB, Jr, Gendy G, Doyle J, years of experience as a medical writer and one of her areas of
Golubic M, Roizen MF. A way to reverse expertise is nutrition and environmental sustainability.
CAD? J Fam Pract. 2014;63(7):356–64b.
29. Li WW, Li VW, Hutnik M, Chiou AS.

www.emwa.org Volume 28 Number 3 | Medical Writing September 2019 | 19

Artificial intelligence –
will we be replaced by robots?
Martin Delahunty stand climate change, regulation and oversight
Director, Inspiring STEM Consulting, London, speed, efficiency, and effectiveness to current are needed to stop the new technology being
UK and increasingly challenged processes and abused.3 Importantly, guidelines are being
systems as well as supporting open science developed for the responsible design and
Correspondence to: principles. implementation of AI systems.4
Martin Delahunty A recent Science article5 reflects on the
Inspiring STEM Consulting practical hurdles and concerns when imple-
+44 7766775174 We cannot fail to be impressed with the menting AI in medicine and states that more
[email protected] increasingly prevalent and dominant news on collaboration is needed before involving patients.
artificial intelligence (AI) advances. Whether it
is the recent announcement by MIT,1 one of the The AI ecosystem
Abstract birthplaces of AI, that it has secured US$1 billion To begin, a common problem is that AI tends to
Advances in artificial intelligence (AI) in funding to create a new college that combines be used interchangeably when actually describing
increasingly dominate the news with billions AI, machine learning, and data science with other one or a number of elements within the vast AI
of dollars in funding invested to combine AI academic disciplines. Or with Eric Topol, the ecosystem, for example, machine learning or
with machine learning and data science across renowned American cardiologist, geneticist, and natural language processing. Figure 1 is therefore
many disciplines, including medicine and healthcare visionary, whose latest book Deep helpful in breaking down, mapping out, and
healthcare. Within the context of scholarly Medicine2 looks systematically at the role that AI communicating to a diverse audience, the many
scientific and academic publishing, AI is seen is playing right now in US healthcare. constituent parts.
also as a potential means of bringing more But there are health warnings. Although AI is
already helping us diagnose cancer and under-

Figure 1. AI applications in healthcare. Reprinted with permission from Mike Quindazzi, PWC.

AI applications in healthcare

Training Keeping well

The use of VR in healthcare has shown major advantages The use of AI and the internet of medical things in
including improving training of healthcare professionals consumer health applications helps people manage their
Keeping
through providing realistic and accurate simulations, thus Training own health and keeps them well. VR has a high potential
improving comprehension and retention.
well to be used as a tool to improve public health issues.

Research Early Detection

Research has shown that digitization can and AI, the use of wearables and other devices can
will help healthcare professionals in making Research Early be applied to detect diseases such as Cancer,
decisions and discoveries much faster than Detection or to monitor cardiac diseases at a very early
they previously could have. It will also pave the stage, allowing doctors to closely monitor those
way to new and emerging jobs. patients and helping them save lives.
Artiocial
End of life care Intelligence
Robotics is being used to care for the elderly, Diagnosis
helping them remain independent, reminding
AI is being implemented across different
them of daily tasks and tracking their progress. End of life Diagnosis hospitals worldwide to solve issues of
Advancements might even go further to include care misdiagnoses. AI has the ability to process
having “conversations” and socialization with
information much faster than any human can,
the elderly.
thus increasing efficiencies and accuracy.

Treatment Decision Decision Making

Treatment
Robotics is being widely used in healthcare, from Making Improving patient care requires the alignment of big
surgery to supporting self management of patients health data with the appropriate and timely decisions.
with long term conditions and for treating psychologi- The innovation of predictive analytics will support
cal conditions. Compared with humans, robots have clinical decision-making and deliver administration
the ability to achieve better health outcomes. priorities and actions.

20 | September 2019 Medical Writing | Volume 28 Number 3

 Delahunty – Artificial intelligence – will we be replaced by robots?

AI and publishing Real-world applications medicine is no exception. AI and digital health

Within the context of scholarly scientific and When looking beyond the AI hyperbole to real- are growing trends and, as medical writers, we
academic publishing, AI is seen as a potential world applications, I was pleased to find one must understand and communicate these
means of bringing more speed and efficiency to impressive example reported in the magazine advances.
current processes and systems, as well as sup- Communications of the ACM (Association for
porting open science principles. Computing Machinery) that demonstrated how Conflicts of interest
In 2018, I gave a broad-ranging talk on various state-of-the-art tools from machine learning and The author declares no conflicts of interest.
AI technologies at the European meeting of the AI are making inroads to automate and improve
International Society for Medical Publication parts of the peer review process7. Allocating References
Professionals – provocatively titled “Will we be papers (or grant proposals) to reviewers is also 1. MIT News. Oct 15, 2018. MIT reshapes
replaced by robots?”. an area in which much progress has been made. itself to shape the future.
But more recently, the experience of working These computational methods have been 2. Topol E. Deep Medicine: How Artificial
with a number of clients and their journal editors used to support other academic processes out- Intelligence Can Make Healthcare Human
brought me back to thinking again about AI’s side of peer review, including a personalised Again. New York: Basic Books: 2019.
potential real-world applications. Therefore, in conference planner app for delegates, an organ- 3. Beall A. It’s time to address artificial
my opinion, the most immediate and pressing isational profiler, and a personalised course intelligence’s ethical problems. Wired, 24
problem that we could try to solve with AI is that recommender for students based on their August 2018.
of peer review. academic profile. 4. Leslie D. Understanding artificial
Web of Science (Clarivate Analytics) reports intelligence ethics and safety: A guide for
that, since 2013, there has been a 2.6% annual We hope that [the future the responsible design and implementation
growth in published articles and 6.1% in article of AI systems in the public sector. The Alan
submissions. Also, a recently published survey6
directions for computational Turing Institute; 2019.
reports that, on average, an editor in 2017 needed support], along with this article, 5. Couzin-Frankel J. Medicine contends with
to send out 2.4 peer review invitations to get one stimulate our readers to think how to use artificial intelligence. Science.
peer review report done, an increase from 1.9 about ways in which the 2019 Jun;364(6446):1119–20.
invitations in 2013. 6. Publons and Clarivate Analytics. 2018
Consequently, the task of finding reviewers
academic peer review process – Global State of Peer Review. Philadelphia:
for an academic peer-reviewed scientific journal this strange dance in which we Publons; 2018.
is projected to get much harder across all all participate in one way or 7. Price S, Flach PA. Computational support
scientific disciplines. Peer review is a core critical another – can be future-proofed for academic peer review: a perspective
function, therefore, to be sustainable and from artificial intelligence. Commun ACM.
successful, journals must be capable of scaling
in a sustainable and scalable 2017 Mar;60(3):70–9.
with increased submissions and increased way.7 8. Emerson RL. The Philosophical Society of
demands on the quality and nature of peer review. – Simon Price and Peter Flach Edinburgh, 1737-1747. Br J Hist Sci. 1979
This will demand significant advancements in Jul;12(2):154–91.
automated technologies, including algorithms for This leaves me excited to see more applications
assigning reviewers and improving reviewer of AI technologies to support the peer review
experience and retention. process. With these applications, we may be able
What we want of AI, therefore, is more to move on from a process that has remained
operational speed and efficiency. AI is already relatively unchanged since the first peer-
beginning to hit the ground in these five areas: reviewed publication Medical
l Identifying new peer reviewers with broader Essays and Observations 8
searches published by the Royal Society Author information
l Fighting plagiarism with software that can of Edinburgh in 1731. Martin Delahunty is
identify components of whole sentences or Company Director of Inspiring
paragraphs rather than verbatim text Further reading STEM Consulting. He is a
l Discovering where authors fail to report key Look out also for the forth- former Global Director at
information that would affect accept or reject coming December 2019 issue of Springer Nature and a past
decisions Medical Writing on the theme Secretary and Board of Trustee
l Spotting statistical errors that generate false Artificial intelligence and digital Member for the International
conclusions health. This issue will show how Society for Medical Publication
l Detecting data fabrication technological innovation is Professionals.
overtaking all industries, and

www.emwa.org Volume 28 Number 3 | Medical Writing September 2019 | 21

Now more than ever, scientists must
speak up for science
Melvin Sanicas from climate change and evolution to the shape (i.e., “I had the flu shot, but I still had colds” –
Takeda Pharmaceuticals International AG, of the earth and even vaccine safety demon- many viruses can cause colds and flu-like
Zurich, Switzerland strated that what you believe depends a lot on the symptoms, not all colds and flu-like symptoms
source of the information (or misinformation). are caused by influenza/the flu). However,
Correspondence to: Thus, what does it really mean to be believing incorrect information about scientific
Melvin Sanicas misinformed or uninformed about science? topics (e.g., childhood vaccination) can have real-
Takeda Pharmaceuticals International AG The word “misinformation” can be defined life consequences, especially if the person is also
Thurgauerstrasse 130 broadly as being information, which is incorrect, vocal and politically active.
8152 Glattpark-Opfikon potentially by accident. Whereas, “disin- Early this year, the World Health Organi-
Zurich, Switzerland formation” refers to a specific type of zation (WHO) released a list of global health
[email protected] misinformation that is intentionally false. threats for 2019.1 Unlike some of the health
However, the distinctions between these terms – challenges on the list, at least one, vaccine
as well as terms like “rumour” or hesitancy, is solvable. Despite
Abstract “fake news” – have not always In this post-truth WHO’s warnings, we are now
In this post-truth era we live in, the validity of been clear in research pertaining era we live in, the seeing a return of vaccine-
facts from climate change and evolution to the to these topics. preventable diseases in many
shape of the earth and even vaccine safety is Moreover, a person who has
validity of facts parts of the world, much of it
challenged by misinformation. As scientists, been “misinformed” is often from climate because of mostly unopposed
we should make greater efforts to engage with defined as someone believing in change and anti-vaccination groups,
the public and to counter misinformation counterfactual claims while the evolution to the historical amnesia, widespread
through publicising correct information on “uninformed” is, simply not misinformation, and the rise of
social media as well as through traditional knowing. People can be both
shape of the earth populist regimes spearheading
publishing channels. We can all start with our misinformed and uninformed and even vaccine the notion of “medical freedom”
friends, family, and colleagues. As scientists, simultaneously. For instance, safety is challenged from vaccines.
we have a responsibility to speak knowl- they could be uninformed about by misinformation. So, what is behind the
edgeably on scientific issues that affect us all. how safety is a core element in decline of trust in vaccines?
all the phases of vaccine There are well-funded and well-
In the 21st century, “fake news”, “alternative development while being misinformed about the organised antivaccine groups in the United States
facts,” and disputes over the validity of everything facts of a specific vaccine-preventable disease and Europe with over 400 internet websites and

22 | September 2019 Medical Writing | Volume 28 Number 3

 Sanicas – Now more than ever, scientists must speak up for science

social media anti-vaccination groups injecting the UK, virologist Dr Susan Nasif from Belgium, Disclaimers
fear into parents about the dangers of vaccines Clinical Pharmacist Dr Artyom Korenevsky from The opinions expressed in this article are the
and fake conspiracies about the vast cover-up by Canada, Law Professor Dorit Reiss, and author’s own and not shared by his
the governments. Social media also creates Pediatrician-Scientist Professor Peter Hotez from employer or affiliated organisa-
insular bubbles of information and online echo the US to name a few. With our combined reach tions or EMWA.
chambers where ideas and misinformation are of over 100,000 followers from all over the
easily reinforced because of the absence of world, we are debunking pseudoscience and Conflicts of interest
diverse viewpoints. Rumours spread not only misinformation, one tweet at a time. The author is employed by Takeda
through social media and online networks but Organisations that fund science or Pharmaceuticals International AG, a
also via families and communities where the represent scientists are beginning to company developing vaccines that
influence is much stronger, and we are paying the encourage greater public interaction and tackles problems in public health
price in terms of global child health. The WHO scientific publishers are seeing the value including dengue, norovirus, Zika, and
reports more than 112,000 confirmed cases of of scientific communication for the public. chikungunya.
measles worldwide, as of May 2019 – a 300% The current climate change poses challenging
increase from the 28,124 cases this time in 2018.2 times for science and the principles that guide all References
Therefore, to counter the populist rhetoric, scientific endeavours. Science, medicine, and 1. Ten threats to global health in 2019. World
we should emphasise how children have a public health are at risk in today’s era of fake news Health Organization. 2019 [cited 2019
fundamental right to be protected against deadly and science denialism.3 We should speak up June 01] Available from:
infections. This right trumps parental choice and when robust scientific findings are being https://www.who.int/emergencies/
“medical freedom”. Scientists and scientific disregarded or treated as mere matters of faith. It ten-threats-to-global-health-in-2019.
associations should anticipate campaigns of does not have to be on social media. We can all 2. New measles surveillance data for 2019.
misinformation and proactively create online start with our friends, family, and colleagues. As World Health Organization. 2019 [cited
strategies to counter them when (not if) they men and women of science, we have a 2019 June 01] Available from:
occur. We also need to become better at responsibility to speak knowledgeably on https://www.who.int/immunization/
communicating scientific data – so we need to scientific issues that affect us all. newsroom/measles-data-2019/en/.
seek the assistance of social science and 3. Sanicas, M 2017. Scientists can vaccinate us
communications experts to know how the public Acknowledgements against fake news. World Economic Forum
values news headlines versus videos clips or The author would like to thank Merlin Sanicas for Agenda. 2017 [cited 2019 June 01] Available
tweets. assistance. from: https://www.weforum.org/agenda/
Scientists should be speaking up about all 2017/08/scientists-can-vaccinate-against-
issues that affect our lives. Now more than ever, the-post-truth-era/.
scientists should be constantly exposing
misinformation, alternative facts, and pseudo-
science. We may have separate roles in the
organisations we work with or work for, but a
Melvin Sanicas cartoon by Ethan Kocak

scientist’s job is not only to analyse laboratory

data, write manuscripts, prepare dossiers, or build
a long list of peer citations. As men and women
of science, our real job should be to make great
discoveries and share them with the rest of the Author information
world. Melvin Sanicas, physician and scientist, is the Medical
With all its flaws, social media has some Director Clinical Excellence at Takeda Vaccines Business Unit.
benefits too. It allows people from all over the He is a TED Educator, a contributor for the World Economic
world to engage, keep up with new findings, and Forum, a global assessor for the Royal Society for Tropical
find new collaborators. Through Twitter, for Medicine and Hygiene, and a fellow of the Royal Society
example, I have started to know fellow science of Arts.
advocates children’s author Andrew Murray from

www.emwa.org Volume 28 Number 3 | Medical Writing September 2019 | 23

When less is more: Medical writers
as guardians of curated content
Laura C. Collada Ali,1 Jackie L. Johnson,2 decision-making. What is the role of medical
and Amy Whereat3 Medical writers are often asked to curate writers?
content, which is defined as the process of Importantly, curators can ensure that the articles
1 Medical Writing & Translation Consultant, gathering information relevant to a particular selected for publication are relevant and of high
Teksema, Cogne, Italy topic or area of interest. It sounds simple, but as quality for the reader. Professional medical
2 Managing Director, JLJ Consultancy BV, Steve Jobs once said, “Simple can be harder than writers are increasingly in demand for content
Amsterdam, The Netherlands complex: You have to work hard to get your curation as they are well trained to understand
3 Medical Communications Consultant, thinking clean to make it simple.”2,3 the quality and relevance of the research. Those
Speak the Speech Consulting, Paris, France medical writers with scientific training and
Content solutions in the experience writing publications are well placed
data-driven era to ensure the information is critically analysed
Correspondence to: These needs are presently being addressed with before reaching the reader. As well as solid
Laura C. Collada Ali the support of scientific content curators. A writing and summarising skills, most experienced
Medical Writing & Translation Consultant content curator collects, collates, and summarises medical writers also have specialist medical
www.teksema.com the most relevant content published in scientific knowledge, and a good understanding of best
Villaggio Cogne 57/A literature or at scientific congresses; the content publishing practices and ethics. They also have a
Cogne curator then shares this information on unique and personal understanding of the
Italy 11012 specialised websites, in newsletters, etc. Table 1 audience, since many medical writers were
+ 39 3203671224 lists some examples of content curators, though scientists or clinicians.
[email protected] many others exist.
Content is usually referred to as being Different projects for medical writers
independent when it is not industry supported. The deliverables for content curation can vary.
Abstract Independent content clients are usually not- Typically, the most important information needs
In this data-driven era, the type and format for-profit associations, organisations, or to be identified and summarised in one or two
of publicly available medical and scientific societies that are run by and for their members. key points. This can be quite a challenge! Writers
information is significantly changing. Medical Patient associations and scientific societies are may need to identify why this information is
writers can serve as guardians of the typical examples. Sponsored important, but also describe
information entering the public domain by content is provided with key study design elements,
ensuring accuracy and highlighting the most support from industry Medical writers can highlight the key results and
relevant studies for all stakeholders, from clients, who have an interest now serve as guardians their significance, and also
pharmaceutical clients to patients. Clinicians in providing information in of the information note any study limitations.
often seek information to stay current with therapeutic areas of interest To ensure the content can be
new medical developments. New tools are to their end-users such as
entering the public digested by time-pressed
available to present this information, and clinicians or the general public. domain: by ensuring readers, some providers
medical writers are working behind the Governmental bodies also accuracy and request that this be presented
scenes to make sure it is useful and accurate. curate scientific information – highlighting the most in no more than 200–300
particularly regulatory drug words. Other providers ask
updates – to inform clinicians
relevant studies for all for a journalistic style with
Houston, we have a problem: about new products and stakeholders, from the key information upfront
too much data here! treatment guidelines. Further- pharmaceutical clients and details following.
The quantity of medical and scientific more, pharmaceutical compa- to patients. For medical congresses,
information is constantly increasing: global nies may hire individual clients may ask that the key
scientific output doubles every 9 years.1 It is medical communication findings be reported as a
becoming nearly impossible to keep up. agencies or freelance medical writers to curate scientific press release (e.g. the style you can see
Importantly, clinicians are expected to stay content being presented live at scientific at Univadis.com), a slide deck, a combination of
up-to-date with the latest research outcomes; yet, congresses. This gives companies the most up-to- the two, or something else entirely! Companies
the increasing amount of new data available date information, though these deliverables are (and medical writers) are increasingly creative
makes it difficult. In this context, time-pressed rarely available in the public domain. This type of with how they present key findings to make the
clinicians need easily accessible, brief, and coverage and reporting is regulated under reading experience easier for their clients.
accurate information to allow informed clinical different laws in each country. Scientific journals also have blog posts, which

24 | September 2019 Medical Writing | Volume 28 Number 3

 Collada Ali et al. – When less is more: Medical writers as guardians of curated content

are usually a lot easier to read than full articles. [For clinicians] l Who funded the study? A pharmaceutical
Medical writers may be responsible for l Does this publication/abstract/poster/talk company or an independent group?
summarising publications and delivering a brief target the needs of clinicians? Did the
text in the form of a blog post. researchers study outcomes that clinicians [For patients]
would be interested in? l Did the researchers study outcomes that
Communicating to the right audience l Where was the study performed, at which patients would be interested in?
The needs of clinicians in practice are quite trial centres, and were there country- or l Where was the study performed, at which

distinct from the needs of students, researchers, ethnic-specific patient populations? trial centres, and were there country- or
or the general public.4 Clinicians usually seek l How did the researchers interpret the results? ethnic-specific patient populations?
brief and accurate information for two reasons: l Does the study answer the research question? l Does the study show a better quality of life for

to stay current with new developments in l Is the patient population in the study similar patients?
medicine relevant to their practice, or to find to the patient population that they treat? l Does the study suggest that patients can have

answers to patient-specific questions.5 With a full l Is the intervention feasible for the population? more control over their own disease or
schedule, clinicians often have no time for l Will the research finding have an impact on condition?
reading new scientific literature. On the other patient care? l How did the researchers interpret the results?

hand, patients, students, and researchers may also l Does the study add new information to l Who funded the study? A pharmaceutical

want to know the latest developments. When treatment algorithms? company or an independent group?
summarising clinical research for patients, writers l Does the study challenge current treatment

need to simplify the language and sentence guidance or present off-label use or both? A trend on the rise for medical
structure so that articles are easy to read and l Does the presentation describe novel writers
understand, while key results are retained in endpoints that challenge current practice?6 With the increasing demand for brief,
context. So how do medical writers do this? l Were the research methods appropriate for summarised, up-to-date information, medical
Medical writers can ask themselves the the study question? writers should be concentrating their efforts on
following questions to tailor texts to different l Does the journal/congress/website present providing comprehensive services for their
audiences: all the information accurately? audiences. Not only are dozens of articles curated

www.emwa.org Volume 28 Number 3 | Medical Writing September 2019 | 25

When less is more: Medical writers as guardians of curated content – Collada Ali et al.

Table 1. Examples of clinical content curators

Organisation or journal Details Frequency, format, and language
Independent curators
European Society of European professional organisation for medical oncology, comprising Online access and regular newsletters; publish
Medical Oncology over 20,000 oncology professionals from over 150 countries approximately 4–7 unique articles per week
Language: English

ESMO.org ESMO is a non-profit publisher of oncology news that ensures clinicians

are kept up-to-date with the latest developments affecting them and their
daily practice.

American Society of ASCO Daily News provides scientific and educational summaries from ASCO Daily News is a print and online
Clinical Oncology oncology conferences and oncology news to ASCO members and newspaper.
oncology healthcare providers. Editorial content is designed to further Language: English
(ASCO) ASCO.org the education and increase the quality of patient care.

Local scientific societies Some examples: seom.org Publish weekly summaries of scientific
literature and news in local languages

Private curators
Medscape Medscape is the leading online global destination for physicians and Publish daily summaries and online content
healthcare professionals worldwide, offering: Language: English
l the latest medical news and expert perspectives.

l essential point-of-care drug and disease information.

l relevant professional education and continuing medical education.

l country-specific sites and free continuous medical education credits.

Univadis.com A free, time-saving medical news and education platform for healthcare Approximately 250 unique articles per week
professionals. Executive summaries aim to keep clinicians up-to-date in across all topics, written in English and
just a few minutes each day. translated into several languages or written in
local languages

Languages: Chinese, Dutch, English, German,

French, Greek, Hungarian, Italian, Japanese,
Portuguese, Romanian, Russian, Spanish

www.sciencedaily.com ScienceDaily features breaking news about the latest discoveries in Daily email digest
science, health, the environment, technology, and more – from leading Language: English
universities, scientific journals, and research organisations.

www.medpagetoday.com MedPageToday is a trusted and reliable source for clinical and policy Daily headlines
coverage that directly affects the lives and practices of health care Language: English
professionals in the USA.
Medical meeting coverage
Free continuous medical education credits

https://www. M3 Medical is a new online medical community for healthcare Daily email digest of healthcare and medical
m3medical.com/ professionals in Europe, Asia and the USA designed to enable members to news on an American and European site in
interact with their peers, collaborate, and gain access to high quality and English, French, German, Italian, Spanish
relevant information and knowledge to support their clinical practice and
professional lives.
Conference diary, conference coverage, blogs, and social networks

Continued opposite

26 | September 2019 Medical Writing | Volume 28 Number 3

 Collada Ali et al. – When less is more: Medical writers as guardians of curated content

Government agencies

AIFA – Italian Summaries of evidence-linked and validated drug updates, and practice Monthly online updates
Regulatory Agency, guidelines Local languages: Italian; Spanish
AEMPS – Spanish
Regulatory Agency.

National Health Service An award-winning website for the general public in the UK, providing Daily online update in English
UK independent health news and information from recent scientific literature.
www.nhs.uk Topics include common illnesses such as cancer, diabetes, neurology, and
lifestyle issues.

Victoria state An award-winning website for the general public in the UK, providing Daily online update in English
government independent health news and information from recent scientific literature.
Australiawww2.health. Topics include common illnesses such as cancer, diabetes, neurology, and
vic.gov.au lifestyle issues.

INSERM An international multidisciplinary publication focused on biology, Regular online updates, thematic issues, and
médecine/sciences (m/s) medicine, and health research. m/s is a French scientific publication that special editions in French
www.medecinesciences. started more than 30 years ago Language: English and French
org

every week in English, they are also being References Available from: http://www.jillhutchison.
translated or written directly in local languages. 1. Nature News Blog. Global scientific output com/simple-can-be-harder-than-complex-
This implies new opportunities for medical doubles every nine years. 2014 May 7. [cited steve-jobs/.
writers and also for medical translators. 2019 Jul 22].Available from: 4. Gruppen LD. Physician information
http://blogs.nature.com/news/2014/05/ seeking: improving relevance through
Conflicts of interest global-scientific-output-doubles-every-nine- research. Bull Med Libr Assoc.
LCCA, JLJ and AW have received consultancy years.html. 1990;78(2):165–72.
fees from Aptus Health International (Univadis), 2. Patient Empowerment Network. The power 5. Thompson ML. Characteristics of
though not relevant to this work. of content curation for healthcare information resources preferred by primary
communities. 2016 Apr 28 [cited 2019 care physicians. Bull Med Libr Assoc.
Acknowledgements Jul 22]. Available from: 1997;85(2):187–92.
The authors would like to thank Barbara https://powerfulpatients.org/2016/04/28/ 6. Grandage, K, Slawson DC, Shaughnessy AF.
Grossman and Marian Hodges for their the-power-of-content-curation-for- When less is more: a practical approach to
invaluable review of this article and their healthcare-communities/. searching for evidence-based answers. J Med
dedication. 3. Jill Hutchison. “Simple can be harder than Libr Assoc. 2002;90(3):298–304.
complex”. 2011 Oct 11 [cited 2019 Jul 22].

Author information
Laura C. Collada Ali is a medical writing and Jacqueline (Jackie) L. Johnson, PhD, is an Amy Whereat is a medical writing and
translation consultant with more than 19 years Expert Scientific Writer at Novartis PLS, and communications consultant with more than
of experience in delivering multilingual the Managing Director of JLJ Consultancy 20 years’ experience in clinical research and
authoring services for leading independent B.V., a med comms agency based in Amster- medical affairs within the pharmaceutical
research organisations and pharmaceutical dam, The Netherlands. She is also co-founder industry and over 10 years’ independent
and medical device companies. She is an active of the Netherlands SciMed Writers Network, consulting and training. Amy is an active
EMWA member, on the EMWA Professional an active EMWA member, and an EMWA EMWA member and on the editorial board
Development Committee (EPDC) and the workshop leader (Congress Coverage). for the EMWA journal, Medical Writing. She
Expert Seminar Series (ESS) Committee. also founded the Medical Writers’ Hub, Paris.

www.emwa.org Volume 28 Number 3 | Medical Writing September 2019 | 27

Predatory publishing – what medical
communicators need to know
Andrea Bucceri,1 Peter Hornung, 2 The problem of predatory turn to ineffective and harmful treatments
and Thomas M. Schindler3 journals checklist.
You may already have heard about “predatory The practices of predatory publishers
journals”, also known as pseudo-scientific undermine the credibility of science. This will
1 Dove Medical Press Limited, London, journals whose sole purpose it is to siphon off directly affect medical communicators because
United Kingdom money from authors. These journals use the open they are part of the scientific endeavour. Medical
2 Norddeutscher Rundfunk, Ressort access (OA) model to publish just about communicators make science accessible. If
Investigation, Hamburg, Germany anything as long as the authors pay the required sources are fouled with bogus science, the texts,
3 Boehringer Ingelheim Phama, Medical fee. The deal is: you pay the money, we publish documents, and summaries based on them will
Writing Europe, Germany without looking at the article too closely (if at also be bogus and the work of medical
all). The author gets a publication to add to the communicators will be devalued.
curriculum vitae and the publisher gets the
Correspondence to: money. Unlike genuine scientific journals,
Thomas M. Schindler predatory journals shortcut the peer-review Open access publishing and
Boehringer Ingelheim Pharma process entirely or substitute it for a superficial how the problem came about
Biberach, Germany pseudo-review. OA publishing makes articles freely accessible
Thomas.schindler@boehringer- Medical communicators may be aware of online upon publication. Contrary to
ingelheim.com predatory journals but may have thought of them subscription-based publishers, whose published
as a peripheral phenomenon. This perception articles are only accessible after payment of a fee
needs to change. or via a subscription, OA publishers cover their
Abstract The number of predatory journals has risen publishing costs by charging authors a publi-
The rise of ”predatory journals”, also known dramatically in recent years and so has the cation fee upon acceptance of a manuscript.6
as pseudo-scientific journals, poses a risk to number of articles published in them. Data from Since it began in the early 2000s, OA publishing
the integrity of science and therefore medical the Northern German Broadcasting Network has grown to become a well-established publi-
communicators need to know about their suggest that, globally, some 400,000 scientists cation model, and currently, many funding
practices. Upon receipt of a publication fee, from all fields have published in such journals.1 agencies and international organisations require
predatory journals publish manuscripts One company, OMICS, accused of platforming that the data derived from the research they fund
regardless of their scientific merit, very often predatory and low-quality journals, prides itself be published in an OA journal.7-10
without any peer review, and without on publishing over 700 journals generating tens The success of OA publishing in science and
providing editorial services. To maximise of thousands of articles per year.2,3 The problem medicine has opened the door for a new type of
profit, such journals disregard all aspects of has become so big that the US fraud that exploits the need of
scientific integrity and foster the Federal Trade Commission has Medical authors to publish their results
dissemination of bad and bogus science, recently obtained a ruling of $50 for career advancement and to
lobby materials, and conspiracy theories. million against OMICS for
communicators may obtain funding. These fraudulent
Publishing in predatory journals can have dire deceptive business practices.4,5 be aware of predatory publishers are now widely
consequences for authors, their careers, and Predatory publishers harm journals but may have known as “predatory publishers”
the reputation of their institutions. Medical science and society as a whole. By thought of them as because of their aggressive and
communicators can help authors avoid falling publishing bad science and by damaging tactics.11 To maximise
prey to predatory publishers. making it available, they under-
a peripheral profit, they want to attract and
mine trust in science and phenomenon. publish as many manuscripts as
scientific progress. Their activities This perception needs possible. Articles are published
allow bogus work to be quoted to change. without the usual standards and
and entered into the literature. processes that genuine publish-
Bad science as a starting point ers adhere to.10-12 Predatory
may lead other scientific investigations astray. publishing is therefore best defined as the
Predatory journals take away money from exploitation of the OA-publishing system for the
taxpayers or grant-giving charities that was made sole purpose of making a profit, while neglecting
available as part of research grants. Even worse, key aspects of scientific rigour and publication
when uninformed patients in desperate situations ethics.
get hold of unfounded, bogus research, they may The number of predatory journals is rising.13

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 Bucceri et al. – Predatory publishing – what medical communicators need to know

Those who publish their good research in predatory journals are unintentionally upgrading
the bad and false science also published there.

Their fraudulent activities are fuelled by the need To mislead authors, some predatory journals has led to an increase in the number of articles
of researchers to publish results to advance their carry names that are similar or even identical to published in these journals and, in turn, possibly
careers and increase their chances to obtain well-known established journals. This is a form even the citation of their articles in policy
funding.11,14 In some countries, professional of hijacking because these journals aim to divert documents and medical guidelines. Because
advancement in science and medicine is directly submissions intended for genuine scientific most predatory journals do not perform a proper
linked to the publication record through a point journals. By misleading authors, they seek to get peer review, they serve as a venue for badly
system.15 Many universities and research hold of scientifically sound content that they can conducted science. It is therefore not surprising
institutions require that PhD students publish then use to obscure the nature of their that conspiracy theorists, such as anti-vaxxers and
their work in a journal – regardless of its quality business.16,17 climate change deniers, use these outlets to
– before awarding a degree. The increasing number of predatory journals publish.18,19 Some predatory publishers do

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Predatory publishing – what medical communicators need to know – Bucceri et al.

perform a pseudo peer-review process, after article published in a predatory journal because predatory journal but want to withdraw it later
which they accept manuscripts regardless of the it did not meet the standards of a genuine will often not succeed because the journal may
recommendations of the peer reviewers.20,21 journal? Was the authors’ priority not scientific want to upgrade its reputation by keeping it.
Although the traditional peer-review system integrity but speed of publication? Authors who are denied withdrawing their work
has its flaws, it remains the best way to evaluate Researchers who have submitted their work have essentially lost the opportunity to publish
scientific content. It has served its purpose quite accidentally to a predatory journal may want to in a genuine journal because this would
well since its systematic implementation in the withdraw it upon realisation. This, however, is constitute a second publication of the same
1970s. One possible way forward is imple- often not possible or only permitted after paying content.
menting “open peer review”. This ensures full an additional fee. Scholars who publish their It is important for authors that their research
transparency to the reader as both the names and research in a predatory journal waste the time, is permanently available to the scientific
affiliations of the reviewers and their comments effort, and money spent conducting it. Public community. With predatory publishers, however,
are available online.22 money or third-party funds are permanent archiving and accessibility
wasted and are no longer available for are not ensured. Should a dubious
The dangers of using genuine research. If scientists are Most predatory publisher go out of business, the
predatory journals for aware of the predatory nature of a journals do not articles published by them may no
authors and their institutions journal and nevertheless publish their
perform a proper longer be available. In addition, there
The opportunity to publish anything in predatory work there, they may even be liable to have been cases where articles were
journals is tempting for some researchers who prosecution. They are liable for using peer review. simply republished under different
want to publish irrelevant or inconclusive results funds on dubious journals and by author names and with slightly
for the sake of career advancement.13 However, incurring expenses for travelling to scientifically different titles without consent of the initial
this carries some long-term risks and authors worthless conferences offered by some predatory authors. Predatory publishers do this to enlarge
should be aware of them. publishers. Research appearing in journals their article database.
Publications in predatory journals harm without scientific value ultimately becomes Those who publish their good research in
science and medicine. Without the scrutiny of worthless to the authors and to the scientific predatory journals are unintentionally upgrading
a proper peer review, it is not possible to community. the bad and false science also published there.
distinguish between good, mediocre, and bad Authors cannot rely in any way on predatory Predatory publishers use the names of well-
science. Good science published in a predatory publishers. Predatory journals are dishonest in known scientists for their marketing purposes. By
journal becomes contaminated and devalued. regard to peer review, they hide the true costs, doing this, they appear genuine, which allows
It loses its credibility because of the context in and they do not abide by rules and agreements. them to obscure their business model. When
which it is placed. Question arise: Was the Authors who have submitted a manuscript to a using predatory journals, serious scientists bring

Table 1: Potential consequences of publishing in predatory journals for individual researchers

Researchers’ work appears in questionable environment. Their work is made available next to mediocre, bad, or even fake science articles.

The researcher’s name and affiliations may be used for advertising by the predatory publisher without their knowledge or consent.

The researcher’s name is permanently linked with the predatory publisher and its website, which may have negative consequences for their academic career.
There is no assurance of permanent archiving, traceability, or accessibility of the article.

Papers are not included in reputable databases because some databases actively remove references to articles published in predatory journals.

Researchers cannot prevent their articles from being re-used by predatory publishers to enhance their database or for advertising.

Researchers may have to pay additional fees, particularly if they request withdrawal of the manuscript.

Public and third-party funds are wasted, resulting in potential liability.

Enforcing rights may be difficult because predatory publishers hide their location to avoid legal action. Even when their location is known, most predatory
publishers fall under other jurisdictions than the authors’, complicating legal action.

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 Bucceri et al. – Predatory publishing – what medical communicators need to know

Table 2. Checklist for identifying predatory journals

Item Details

Overall Look at the totality of the evidence; failure in complying with one item does not necessarily indicate a predatory journal.

Membership in a Absence of membership in reputable open access association such as the Open Access Scholarly Publishers Association
reputable publishing (https://oaspa.org/), World Association of Medical Editors (http://www.wame.org), Committee on Publication Ethics
association (https://publicationethics.org/), and Directory of Open Access Journals (https://doaj.org/) is a sign of likely being a
predatory journal.

Website design and use Spelling and grammar mistakes or poor web design are indicative of predatory journals.
of English language

Transparency about fees Not clearly showing fees on the journal website is a sign of a likely predatory journal.

Editorial Board Not being able to verify the identity the Editorial Board members with the information provided by the journal is a sign of a
Members likely predatory journal.

Editorial office contact Not being able to verify a publisher’s location, phone numbers, or email address is a sign of a predatory journal.
details

Scientific quality of If the articles published by the journal are not well written, if you have not heard about the other authors that publish in the
articles journal, and if you have never heard of the institutions mentioned, this could indicate a predatory journal.

Submission process Providing only an email address as a method of submitting manuscripts is a sign of a likely predatory journal, as opposed to
using a recognised submission system such as ScholarOne.

Digital Archiving Not participating in a recognised digital archiving system, such as CLOCKSS (https://clockss.org/), is a sign of likely being a
predatory journal.

Indexing Not being included in a recognised index, such as PubMed Central is a sign of likely being a predatory journal
(http://www.ncbi.nlm.nih.gov/nlmcatalog?term=journalspmc).

Journal Impact Factor Not being able to verify that a claimed Impact Factor can be found in the Journal Citation Report website
(https://clarivate.com/products/journal-citation-reports/)26 is a sign of likely being a predatory journal.

Adherence to ethical Absence of policies dealing with the disclosure of conflicts of interest and absence of statements on copyright, intellectual
standards property, or publishing licences are indicative of a predatory journal

themselves down to the level of researchers of they do not realise what they were doing. continue unabated, science may become viewed
dubious reputation, wannabe scientists, conspir- Researchers who did not know about the with suspicion. If the public, politicians, and the
acy theorists, and lobbyists. For example, climate predatory nature of a journal, expose their media can no longer tell good from bad science,
change sceptics are publishing papers rejected by ignorance and naivety. If they consciously use its impact on society will be lost. This loss of trust
serious journals in predatory journals.19 predatory journals, they might be accused of in science may negatively influence funding
Unethical companies publish pseudo-studies in deliberate deception. Researchers should not decisions and the availability of an adequate
predatory journals to use the apparently genuine count on the possibility that their publications in research infrastructure.
scientific reference to market their ineffective and predatory journals will disappear from the
potentially dangerous treatments. Anti-vaxxers internet at some point. Throughout their career, How to avoid predatory journals
spread their theses (“Vaccinations cause they will have the stigma of having used such an Although there is no golden rule for identifying
autism!”) in predatory journals. outlet; even years later, references to articles a predatory journal, there are certain common
Researchers risk their reputations and careers, published in predatory journals can be found by characteristics.10-12 One can avoid falling prey to
as well as the reputation of their institutes when commonly used search engines. predatory publishers by checking some free
they publish in predatory journals, even when Should the growth of predatory journals online checklists such as the Think.Check.

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Predatory publishing – what medical communicators need to know – Bucceri et al.

Submit checklist23 and the Centre for

Journalology at The Ottawa Hospital checklist.24
Critical items are summarised in Table 2.
Taken individually, the items listed do not
necessarily prove that a journal is predatory.
However, if several items do not apply, the
likelihood of dealing with a predatory journal is
high.
Because fraudulent publishers tend not to
invest in website design or English language
proofreading, their websites and emails often
contain spelling mistakes, poor grammar, and
poor design elements, such as low-resolution
logos or images or overlapping text.
Names of editorial board members of
predatory journals are sometimes entirely made
up. They may also use names of genuine
healthcare professionals without their knowledge
or consent. Therefore, if the identity of the
editorial board members cannot be verified, this
may indicate the predatory nature of a journal.
Few genuine science publishers do not yet use
a recognised submission system such as
ScholarOne. Therefore, if a journal asks authors
to send their manuscript simply to an email
address, the alarm bells should start ringing.
Faking impact factors and indexing features is
very common among predatory journals.
Because of this, it is advisable to check their
claims in the Journal Citation Report26 and that the journal is not predatory because the References
PubMed Central. associations carefully scrutinise journals before 1. Dossier: Das Geschäft mit der
Lack of commitment to digitally archiving the admitting them as members.25 Wissenschaft, Norddeutscher Rundfunk,
published articles in a safe repository is also NDR. 2019 [cited 2019 Jun 14]. Available
common among predatory publishers. A Conclusion from: https://www.ndr.de/nachrichten/
reputable journal will likely participate in a Medical communicators need to know about all investigation/Dossier-Das-Geschaeft-mit-
recognised digital archiving system, such as aspects of predatory publishing because it not der-Wissenschaft,fakesciencedossier
CLOCKSS (https://clockss.org/). only undermines the credibility of science but 100.html.
Finally, being a member of an international may also have serious consequences for authors, 2. Gastroenterology & Endoscopy News,
OA organisation such as the Open Access their careers, and their institutions. Medical Wysong P. Beware predatory journals –
Scholarly Publishers Association (https://oaspa. communicators are often asked to support more than 40 target gastroenterology.
org/) or the Committee on Publication Ethics selecting an appropriate journal, therefore they 15 April 2019 [cited 2019 Apr 15].
(https://publicationethics.org/) is a good sign are in a key position to help authors avoid falling Available from:
prey to predatory publishers. https://www.gastroendonews.com/In-the-
News/Article/04-19/Beware-Predatory-
Few genuine science publishers do Disclaimers Journals%E2%80%94-More-Than-40-
The opinions expressed in this article are the Target-Gastroenterology/54558.
not yet use a recognised submission author’s own and not necessarily shared by their 3. Bauer P, Krause T, Kropshofer K, Langhans
system such as ScholarOne. employers or EMWA. K, Wagner L. Das Scheingeschäft.
Therefore, if a journal asks authors Süddeutsche Zeitung Magazin. 11 July
to send their manuscript simply to Conflicts of interest 2018 [cited 2019 Jun 1]. Available from:
The authors declare no conflicts of interest. https://projekte.sueddeutsche.de/artikel/
an email address, the alarm bells wissen/angriff-auf-die-wissenschaft-
should start ringing. e398250/?reduced=true.

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 Bucceri et al. – Predatory publishing – what medical communicators need to know

4. Kolata G. The price for ‘predatory’ 12. Clark J, Smith R. Firm action needed on 20. Edie AH, Conklin JL. Avoiding predatory
publishing? $50 million. New York Times. predatory journals. BMJ 2015;350:h210. journals: quick peer review processes too
3 April 2019 [cited 2019 Jun 1]. Available 13. Shen C, Bjork B-C. “Predatory” open good to be true. Nurs Forum. 2019
from: https://www.nytimes.com/ access: A longitudinal study of article Jul;54(3):336–9.
2019/04/03/science/predatory-journals- volumes and market characteristics. BMC 21. Fernandez-Llimos F. Open access,
ftc-omics.html. Med. 2015;13:230. predatory publishing and peer-review.
5. Dyer O. US consumer agency wins $50m 14. Manca A, Martinez G, Cugusi L, Dragone Pharm Pract (Granada). 2014;12(1):427.
order against predatory publisher OMICS. D, Dvir Z, Deriu F. The surge of predatory 22. Johnson R, Watkinson A, Mabe M. The
BMJ. 2019;365:l1639. open-access in neurosciences and STM Report - An overview of scientific and
6. Laakso M, Welling P, Bukvova H, Nyman neurology. Neuroscience. 2017 Jun 14; scholarly publishing 2018. Oxford (UK):
L, Björk B-C, Hedlund T. The development 353:166–73. International Association of Scientific,
of open access journal publishing from 15. Bolshete P. Analysis of thirteen predatory Technical and Medical Publishers.
1993 to 2009. PLoS ONE. 2011;6(6): publishers: a trap for eager-to-publish Available from https://www.stm-
e20961. researchers, Current Med Res Opin. assoc.org/2018_10v04_STM_Report_
7. Rabesandratana T. European funders detail 2018;34(1):157–62. 2018.pdf.
their open-access plan. Science 16. Butler D. Sham journals scam authors. 23. Think.Check.Submit Checklist, choose the
2018;362(6418):983. Nature. 2013;495(7442):421–2. right journal for your research. 2019
8. Schiltz M. Science without publication 17. Dadkhah M, Borchardt G. Hijacked [cited 2019 Jun 20] Available from:
paywalls: cOAlition S for the realisation of journals: an emerging challenge for https://thinkchecksubmit.org/.
full and immediate Open Access. PLoS scholarly publishing. Aesth Surg J. 24. The Ottawa Hospital Research Institute,
Biol. 2018 Sep 4;16(9):e3000031. 2016;36(6):739–41. Centre for Journalology. How to detect a
9. Hunter P. A DEAL for open access. EMBO 18. Skeptical Raptor. Another anti-vaccine potential predatory/deceptive journal.
Rep. 2018;19, e46317. article – bad journal, bad data. 1 Feb 2017 [cited 18 August 2019]. Available from:
10. Baker EF, Iserson KV, Aswegan AL, Larkin [cited 2019 June 20]. Available from: http://www.ohri.ca/journalology/docs/
GL, Derse AR, Kraus CK and the American https://www.skepticalraptor.com/ How%20to%20detect%20a%20predatory
College of Emergency Physicians Ethics skepticalraptorblog.php/another-anti- %20checklist.pdf.
Committee. Open access medical journals: vaccine-article-bad-journal-bad-data/. 25. Laine C, Winker MA. Identifying
promise, perils, and pitfalls. Acad Med. 19. Readfearn G. Murky world of ‘science’ predatory or pseudo-journals. Biochem
2019;94(5):634–9. journals a new frontier for climate deniers. Med (Zagreb). 2017;27(2):285-291.
11. Shamseer L, Moher D, Maduekwe O, et al. The Guardian. 28 Jan 2018 [cited 2019 Jun 26. Clarivate Analytics. Journal Citation
Potential predatory and legitimate 20]. Available from: Reports 2018. 2019 [cited 2019 Jun 20].
biomedical journals: can you tell the https://www.theguardian.com/ Available from: https://clarivate.com/
difference? A cross-sectional comparison. environment/planet-oz/2018/jan/24/ blog/science-research-connect/the-2018-
BMC Med. 2017;15:28. murky-world-of-science-journals-a-new- jcr-release-is-here/.
frontier-for-climate-deniers.

Author information
Andrea Bucceri, PhD, has spent over 10 years Peter Hornung, MA, studied political science Thomas. M. Schindler, PhD, studied biology
in scientific research in Italy, The Netherlands, and history in Vienna and Regensburg, as well as and linguistics in Germany and the UK, then
and Switzerland, where he earned a PhD in journalism in Mainz. He worked as an editor, obtained a PhD in molecular physiology and
Molecular Genetics at the ETH Zurich. After a presenter and reporter at the Hessischer Rundfunk continued with postdoctoral training in the UK.
postdoc, he moved to Open Access Scientific (radio), before becoming a correspondent and Thereafter he went into publishing and became
Publishing. For a few years, he worked in bureau chief of ARD German Broadcasting in a popular science editor. He turned to medical
medical communications for pharmaceutical Prague, Czech Republic. He is currently an writing and has now gained some 22 years of
companies before becoming Publication editor and investigative reporter at experience in both medical affairs and
Development Manager at Dove Medical Press Norddeutscher Rundfunk and a research regulatory medical writing. He is currently the
(now part of Taylor & Francis Group, an lecturer at the Academy for Journalism in head of the European Medical Writing Group at
Informa Business). Hamburg. Boehringer Ingelheim Pharma.

www.emwa.org Volume 28 Number 3 | Medical Writing September 2019 | 33

AMWA – EMWA – ISMPP Joint Position
Statement on Predatory Publishing
American Medical Writers Association, European Medical Writers Association, and International
Society for Medical Publication Professionals

Harm to the scientific literature will be the l a lack of journal indexing in a recognised
The American Medical Writers Association ultimate result if predatory publishing proliferates. citation system such as PubMed13 or within a
(AMWA), the European Medical Writers Legitimate research carried out with the best of legitimate online directory such as the
Association (EMWA), and the International intentions might be lost if it is not recorded, cited, Directory of Open Access Journals (DOAJ)14
Society for Medical Publication Professionals or made accessible in the long term, and the l promises of unrealistically quick peer review,
(ISMPP) recognise the challenges to scientific scientific record is at risk of being corrupted.1 But or no information provided about a journal’s
publishing being posed by predatory journals and dangers to authors also exist in that their peer-review process
their publishers, which employ practices underm- reputations can be damaged as a result of having l article processing charges that are not trans-
ining the quality, integrity, and reliability of their work published in predatory journals or parent (and may be either very high or very
published scientific research. This joint position being unknowingly “appointed” to their editorial low) or are payable on submission (that is, not
statement complements several other sets of boards. Furthermore, authors may find them- dependent on the outcome of peer review)
guidelines that have helped define the charac- selves trapped after they realise they have sub- l claims made of broad coverage across multi-
teristics of a predatory journal.1-5 mitted an article to a predatory journal. There is a ple specialties in medicine or across multiple
potential risk that some journals might not return subspecialties in a particular discipline
Predatory journals pose a serious threat both to submitted manuscripts or will publish a submitted l a large stable of journals that have been
researchers publishing the results of their work paper even after an author has protested. started very recently and/or that contain no
and to the peer-reviewed medical literature itself. The large increase in scientific journals, or few published articles, are inaccessible, or
These publications differ from legitimate open- including those that are predatory,12 over the past are of obviously poor quality
access journals6 in that predatory journals 15 years can make the task of distinguishing l an editorial board consisting of members
subvert the peer-review publication system for predatory or “pseudo” journals difficult. How- from outside the specialty or outside the
the sole purpose of financial gain with little ever, online tools are available to help authors in
evident concern for ethical behaviour.7 this effort,1,8 and certain characteristics have
Organisations such as the World Association been identified as being typical of predatory This article was originally published online
of Medical Editors (WAME), the Committee on journals and their publishers: July 29, 2019, in Current Medical Research
Publication Ethics (COPE), the International l publishers or journals sending emails that and Opinion, Volume 35, Issue 9.
Committee of Medical Journal Editors (ICMJE), aggressively solicit researchers https://doi.org/10.1080/03007995.2019.
and the Council of Science Editors (CSE) l a journal name that sounds somewhat familiar 1646535
support good publication practices that are now – but is actually a devious permutation of a This is an open access article that is being
widely recognised.6,8-10 Predatory journals do not legitimate journal name republished under the terms of the Creative
adhere to these practices but instead exploit the l a website that appears unprofessional, with Commons Attribution License
Gold Open Access publishing model (for which poor graphics, misused language, dead links, (http://creativecommons.org/licenses/by/
authors pay a publication fee).11 To generate and aggressive advertising 4.0/), which permits unrestricted use,
revenue, these journals intentionally misrepresent l no street address or in-country telephone distribution, and reproduction in any
practices of editorial and peer review, methods of number noted on the journal or publisher’s medium, provided the original work is
journal operation, article process charging, website, or a fake address/phone number properly cited.
dissemination, indexing, and archiving.1 provided

34 | September 2019 Medical Writing | Volume 28 Number 3

 country in which the journal is published, or Julia Donnelly, EMWA; Jan Seal-Roberts and Journal Editors. Responsibilities in the
board members who are unknown to some- Donna Simcoe, ISMPP), and the organisational Submission and Peer-Review Process.
one experienced in publishing in the field reviewers (Shari Rager, AMWA; Tiziana von [cited 2019 June 18] http://www.icmje.
l a submission system that is overly simple with Bruchhausen and Beatrix Doerr, EMWA; Anna org/recommendations/browse/roles-and-
few questions asked and no conflict-of-inter- Geraci and Al Weigel, ISMPP). responsibilities/responsibilities-in-the-
est or authorship qualification information submission-and-peer-peview-process.html.
requested. References: 9. Council of Science Editors. Predatory or
1. Laine C, Winker MA. Identifying predatory Deceptive Publishers – Recommendations
Authors should not purposely choose to submit or pseudo-journals. World Association of for Caution. [cited 2019 June 18]
manuscripts to predatory journals to augment Medical Editors. [updated 2019 Jun 18; https://www.councilscienceeditors.org/
their own record of publication, as has been seen cited 2019 June 18] http://www.wame. resource-library/editorial-policies/cse-
more recently.15,16 The conscious and deliberate org/identifying-predatory-or-pseudo- policies/approved-by-the-cse-board-of-
submission of manuscripts to predatory journals journals. directors/predatory-deceptive-publishers-
is not ethical. Medical writers and editors, as well 2. Cabell’s Blacklist Violations. [cited 2019 recommendations-caution.
as researchers, have a responsibility to evaluate June 18] http://www2.cabells.com/ 10. Berger M. Everything You Ever Wanted to
the integrity, history, practices, and reputation of blacklist-criteria. Know About Predatory Publishing but
the journals to which their research is submitted.8 3. Cobey KD, Lalu MM, Skidmore B, Were Afraid to Ask. [cited 2019 June 18]
We encourage all authors to carry out due Ahmadzai N, Grudniewicz A, Moher D. http://www.ala.org/acrl/sites/ala.org.acrl/
diligence by examining the reputation of the What is a predatory journal? A scoping files/content/conferences/confsandprecon
publications to which they submit, and send their review. Version 2. F1000Res. 2018;7:1001. fs/2017/EverythingYouEverWantedtoKno
work only to those journals that provide proper 4. Beall J. Predatory publishers are corrupting wAboutPredatoryPublishing.pdf.
peer review and that genuinely seek to contribute open access. Nature. 2012;489:179. 11. Mizera K. What is Gold Open Access –
to the scientific literature. 5. Beall’s List of Predatory Publishers. [cited useful links. [cited 2019 June 18]
The scientific community must be made fully 2019 June 18] http://openscience.ens.fr/ https://openscience.com/what-is-gold-
aware of the harm that publishing in predatory ABOUT_OPEN_ACCESS/BLOGS/ open-access/.
journals poses and understand how to avoid it. 2017_01_23_Jeffrey_Beall_last_list_of_ 12. Shen C, Bjork BC. ‘Predatory’ open access:
AMWA, EMWA, and ISMPP are committed to predatory_journals.pdf. a longitudinal study of article volumes and
educating our members about predatory pub- 6. Open Access Scholarly Publishers market characteristics. BMC Med.
lishing and the responsibilities of medical writers Association – Code of Conduct. [cited 2015;13:230.
and publication professionals in addressing this 2019 June 18] https://oaspa.org/ 13. PubMed. [cited 2019 June 18]
significant issue. membership/code-of-conduct. https://www.ncbi.nlm.nih.gov/pubmed.
7. International Committee of Medical 14. Directory of Open Access Journals. [cited
Acknowledgements Journal Editors. “Fake,” “Predatory,” and 2019 June 18] https://doaj.org/.
This joint position statement was reviewed and “Pseudo” Journals: Charlatans Threatening 15. Moher D, Shamseer L, Cobey KD, et al.
approved by representatives of AMWA, EMWA, Trust in Science. [cited 2019 June 18] Stop this waste of people, animals and
and ISMPP. Preparation of this statement was http://www.icmje.org/news-and- money. Nature. 2017;549:23–5.
possible thanks to the efforts of the members of editorials/fake_predatory_pseudo_ 16. Sharma H, Verma S. Predatory journals: the
the Writing Committee (Barbara Good and journals_dec17.html. rise of worthless biomedical science. J
Mary Kemper, AMWA; Slavka Baronikova and 8. International Committee of Medical Postgrad Med. 2018;64:226–31.

www.emwa.org Volume 28 Number 3 | Medical Writing September 2019 | 35

How to combat medical
misinformation with a
sound content strategy
Diana Ribeiro1 and Mathew Wong2 What is content?
Every piece of information and communication
1 Apothecary Medical Writing, Cascais, is content, and can span multiple forms of media
Portugal from written articles, social posts, videos,
2 Bang Albino Communications, Toronto, podcasts, infographics, and more.
Canada Using content for marketing purposes is a
common practice among companies, telling
stories to attract and retain customers. One of the
Correspondence to: earliest examples of content strategy was
Diana Ribeiro pioneered by Johnson & Johnson in 1888.1 They
Apothecary Medical Writing published a manual that thoroughly explained
+351 916225822 how to prevent infections using antiseptic
[email protected] methods and provided information on their
available products.2 This example illustrates the forms of media and communications for a
three core principles of content strategy. Through specific project or purpose. The project can span
Abstract the widespread use of the manual, they raised from a single journal article, product ad
In our post-truth era of media and awareness of the problem, created a desire to campaign, public relations for a company, or
communications, implementing a sound address the problem, and more importantly, organisations for chronic disease. The current
content strategy can help your message reach directed people towards their products as a need for many healthcare companies and
the right individuals. It is time for experts and solution. organisations, is to establish trust, build
healthcare companies to lead the change as Successful marketing campaigns are not awareness, and provide a clear action for the
ethical and credible sources of knowledge. In limited to selling healthcare related products or consumer to take.
this article, we provide insights about the devices. Many public health initiatives have their Having a sound strategy clears a path for your
importance of content strategy, and how roots in marketing. This is exemplified with the message.
collectively, we as medical writers must use current marketing efforts in support of mental Content strategy includes identification of the
our expertise to communicate complex health.3 For many years, society had the problem, defining the communication goals,
concepts and motivate a change of opinion. erroneous perception that mental health issues identifying the audience you need to reach, and
could just be “dealt with” or people can “get over planning all of the communications required to
it”. In 2001, the Mental Health achieve the objective. This may seem like a major
Foundation sought to oversimplification, but these are the core
Are we doing enough to fight challenge those stigmas and principles to
back against widespread launched its first Mental keep in mind
medical misinformation? Health Awareness Week in the as a medical
We live in an age where people are influenced by UK. Breakthroughs made by this writer.
purposeful misinformation, “alternate facts”, and marketing campaign includes the
influencers’ articles across all media and com- recognition and support of mental The power
munications. This deluge of “fake news” has health in the workplace. The public of information
delegitimised content for the general population awareness garnered through the long A medical, scientific, or
to the point of meaninglessness. We have wit- running campaign has led to a commitment clinical background and training
nessed the rise and persistence of misinformation of £2.3 billion a year for mental health is essential to content strategy and
by popular social media influencers and services by 2023/24 from the NHS.3 writing. Medical writers are in a
celebrities, supported by biased or misappro- unique position to understand the
priated scientific research. Why does strategy complexities of the problem at hand
matter? and strategise the types of content
Content strategy required to tackle the problem.
A guiding definition of content strategy Our core knowledge and innate
is the planning and management of all ability to think critically are required

36 | September 2019 Medical Writing | Volume 28 Number 3

 Ribeiro and Wong – How to combat medical misinformation with a sound content strategy

to clearly and accurate convey our message. The at its core, you are an educator to groups of remember to adhere to our ethical code and turn
challenge is that we must hone our skills to tell a potential decision-makers. The scale of decisions down or steer away from creating more
compelling story that resonates with our made by your audience is wide-ranging, which misinformation. When it comes to content
audience and gives them a reason to believe the could include healthcare professionals like development, you may feel pressured to fabricate
science. doctors, nurses, and scientists, or those outside or exaggerate claims about the efficacy of certain
Some of us might wonder how can people of the clinical sector with industry business unit products. Part of medical writing is to stand up
believe things that were proven wrong by science members, patient advocacy members, and the for the scientific principles and not editorialise or
so long ago, or how can certain bad advice be general public. Ultimately, you will be in charge stylise the data. This challenge has grown as you
taken as ‘gospel truth’ when scientific research is of ensuring the message is clear and understood often must be prepared to fact-check sources and
at our fingertips. There is an abundance of by each of these individuals. Your work informs root out any potential agenda-driven biases that
scientific data in the literature, but these are everyone, whether it is an individual’s choice to are inherent to the study design or source of
hidden away from the typical lay-person with get a vaccine, updating a hospital about the latest funding. A good content strategy leverages your
publisher paywalls and confusing best clinical practices, helping venture judgement on the validity of the scientific
jargon. For all good research out capitalists invest in start-up information and will screen out poor or deceitful
there, most people don’t see We live in an age healthcare companies, or brief sources.
anything beyond bad science where people are legislative committees that Another key aspect of content strategy is for
reporting in news headlines. are forming new public the most part, you are working on a two-way
Another challenge, no
influenced by purposeful health policies. communication platform. Be mindful of what
matter what our back- misinformation, “alternate The guiding principle is many of your audience members are saying and
grounds are and how facts”, and influencers’ to never “dumb it down”. don’t hesitate to devise strategies that open direct
rational and logical we think articles across all media We aim to distil the core engagement. You have the unique opportunity to
ourselves, is that research meaning of the principles of understand at an individual level of needs and can
shows that people make decisions
and communications. science to build trust and help bridge any gaps in understanding. These can
primarily using emotions, and understanding. It remains crucial include accounting for having a respondent in
then use logic to back up those that you know your audience and can social media posts, direct messages, and how to
decisions,4 in what is referred to as confirmation tailor your message to them, without distorting liaise with medical, legal, and regulatory
bias. That is why it is important to emphasise that the facts. If you know your audience has a low personnel in the industry.
the role of the medical writer is to bring the degree of literacy or low technical fluency, don’t
crucial information out and make a meaningful overcomplicate your message to reach them. The future of content strategy
connection with your intended audience. No matter how technologically advanced media in healthcare
has become, building trust as a voice of People are weary of fake news and perhaps post-
Making a difference as a knowledge remains a core tenant of medical truth has its days numbered. There is a growing
medical writer writing. sentiment out there for the truth and fair
The typical role of a medical writer may vary, but With medical content strategy, we must also representation of facts. We must always strive for

www.emwa.org Volume 28 Number 3 | Medical Writing September 2019 | 37

How to combat medical misinformation with a sound content strategy – Ribeiro and Wong

transparency and honesty when developing our References

content. Content strategy and medical writing 1. Content Marketing Institute. The History of Author information
are about meaningful, understandable, and Content Marketing. 2016 [cited 2019
compelling messages to inform and persuade the Apr 29]. Available from: Diana Ribeiro, MSc, is a pharmacist with
lay audiences. https://contentmarketinginstitute.com/ over ten years of experience in the healthcare
Overall, it must be stated that: You are a 2016/07/history-content-marketing/. industry. Her love for communicating science
champion of knowledge in the medical field, you 2. Johnson & Johnson. Methods of antiseptic resulted in the creation of Apothecary
can be an advocate for changing practices, and wound treatment. New York: Johnson & Medical Writing, where she provides writing
you are an educator of scientific and medical Johnson; 1888. Available from: services for biotechnology and pharma-
communications for many decision-makers. https://openlibrary.org/books/ ceutical companies.
OL24446970M/Modern_methods_of_
Disclaimers antiseptic_ wound_treatment. Mathew Wong, MSc, is a medical writer and
The opinions expressed in this article are the 3. Mental Health Foundation. Mental Health content strategist working in the healthcare
authors’ own and not necessarily shared by his or Awareness Week. [cited 2019 Jul 19]. communications and continuing medical
her employer, or EMWA. Available from: education fields. He is passionate about
https://www.mentalhealth.org.uk/ educating the general public about science,
Conflicts of interest campaigns/mental-health-awareness-week. medicine, and healthcare. He has also worked
The authors declare no conflicts of interest. 4. Lerner JS, Li Y, Piercarlo V, Kasam KS. closely with many biotechnology, medical
Emotion and Decision Making. Annu Rev device, and pharmaceutical companies world-
Psychol. 2014;66:799–823. wide to develop engaging and accessible
content.

Save the date: EMWA

Conference in Sweden

MALMÖ
November 7-9, 2019

https://www.emwa.org/conferences/future-conferences/

38 | September 2019 Medical Writing | Volume 28 Number 3

 EMWA is a member-run organisation
When you volunteer to assist EMWA in any capacity, you are
furthering the development of our association.
You can choose how you want to get involved: in a very limited way
or as part of a larger project. The choice is yours, and everyone
shares the benefits.

EMWA members can volunteer Internship project

in the following areas:
Special Interest Groups
Conference n Pharmacovigilance
n Planning committee n Regulatory Disclosure
n Advertising n Medical Devices
n Ambassador programme

Finance Executive Committee

n President
Journal n Vice President
n Contributions n Journal Editor
n Editorial Board n Public Relations
Chair
n Conference
Website
n Contributions Chair
n Honorary
n Web Team
Secretary
n Professional
Freelance Development
Business Group Programme
Committee Chair
n Treasurer
Social Media Team
WHY VOLUNTEER?
Training TO FIND OUT n Help promote the role of medical writers
n Leading workshops MORE and strengthen our association
n If you are a member n Help to raise standards in our field
Professional Development
of EMWA and eager n Increase your visibility and communication
Programme Committee
n Webinar contributions to support ongoing opportunities within the medical writing
n Webinar Team initiatives, community
please contact n Add some prestige to your CV
[email protected]. n Improve your knowledge of medical
writing and related topics

www.emwa.org Volume 28 Number 3 | Medical Writing September 2019 | 39

Subcontracting:
Not for the faint of heart
Brian G. Bass, MWC own. The reason is simple. When hiring a
Bass Global, Inc., Fort Myers, FL, USA freelancer, clients cannot afford to make a bad
choice.
Clients only call on freelancers when there’s
Correspondence to: an emergency. They have a project, a deadline,
Brian Bass, MWC and either no one on staff with the requisite
Bass Global, Inc. qualifications, or no qualified person on staff who
11668 Stonecreek Circle is available to do the job. They must turn to
Fort Myers, FL 33913-9083 someone outside their company. They will call
239-561-0199 their familiar freelancers first – the people who
[email protected] have already proved themselves to be not only
good writers but also good at getting things done
and doing them right. If a client is calling you and
Abstract they have never worked with you before, you can
Subcontracting can be the answer to a bet they are out of options. They are nervous.
successful freelancer’s prayers, or the This is why I love being a freelancer. Whether it
opportunity to work harder than you have is a client I know or a client I have never worked
ever worked before for less money than you with before, every time the phone rings is an
made when you were a struggling newbie. opportunity for me to be a hero.
The potential advantages of subcontracting Nobody’s born a freelance medical writer.
are numerous, including being able to meet Whatever our backgrounds, we make ourselves
more of your clients’ needs, expanding your into good writers and then into good freelancers.
reputation and your repertoire, reducing your We become popular with our clients, who put us
personal writing workload, and making more on speed dial, recommend us to their colleagues,
money – even while you are sleeping. But the and take us with them on their career journeys to
potential disadvantages of subcontracting are new positions, new companies, and new
also numerous and very real. Subcontracting opportunities. We have more work than we know
puts your reputation on the line and out of what to do with, but dare we turn anything away?
your hands and exponentially increases your And still, we see more opportunities…if only
risk for problems ranging from cash flow and there were more than 24 hours in a day and seven
liability exposure to conflicts of interest. days in a week! To paraphrase Tennyson, when
Subcontracting is not a decision you make work is consistently too busy, a freelancer’s fancy make extra money and explore new types of
lightly, but neither was your decision to lightly turns to thoughts of subcontracting. writing. In 1989 I quit my perfectly good day job
freelance. It might just be your opportunity Remember the fear and/or apprehension you and started my freelance business. I began
to soar. felt when you decided to take the plunge into specialising exclusively in medical communi-
freelancing? Well, if quitting your cations in 1994 and started
staff position and launching a subcontracting in 2003. In the
Any seasoned freelance medical writer will tell freelance business is like If quitting your staff 16 years I have been sub-
you that success has little to do with being a good jumping out of a perfectly good position and launching contracting I have seen a lot.
writer. Being a good writer is fundamental to the airplane without a parachute, a freelance business is If you think freelancing can
task and therefore expected, assumed. Being subcontracting is like building be tough, subcontracting can
good at what you do is your ticket to the dance; a new airplane for yourself
like jumping out of a be exponentially tougher. It
but once inside, there are a lot of people waiting while you are on the way down. perfectly good airplane can also be more rewarding –
to be invited out onto the dance floor. This is why It is not for the faint of heart without a parachute, personally, professionally,
I have long counselled people who are new to the and not a decision you make subcontracting is like and financially. I will share
field of medical communications to get in with a lightly. with you what I consider to
good company, develop your skills, and learn the Early in my professional
building a new airplane be the main advantages and
industry from the inside out. Only then can you writing career, freelancing was for yourself while you disadvantages of subcon-
even begin to think about striking out on your my side hustle. It enabled me to are on the way down. tracting.

40 | September 2019 Medical Writing | Volume 28 Number 3

 Bass – Subcontracting: Not for the faint of heart

on the project schedule. If my answer to either we are likely to be the solution. If a project
The advantages of question is no, I look to the freelancers on my happens to be outside of our team’s therapeutic
subcontracting team to see who has the right background and areas of expertise, our clients will often offer the
There are numerous advantages to sub- experience as well as the time to get involved. assignment to us anyway because they are
contracting, and these are my top six: Thanks to subcontracting, my freelance business confident in how we consistently deliver for
is able to say yes to many more projects, them. In my experience, clients prefer to give a
1. Meet more clients’ needs providing greater value to our clients and creating project to a freelancer they know despite it being
As a freelancer, my first priority is to keep myself more great work opportunities for me and my in a therapeutic area they don’t know, rather than
busy writing. Writing is what I love to do, and the team. give it to an unknown freelancer who says they
projects I work on are fun and challenging. know the therapeutic area. This gives us the
Subcontracting enables my freelance business to 2. Expand your reputation and your repertoire opportunity to expand our repertoire, making
be a bigger solution for my clients than what Our job as freelancers is to make our clients’ lives our group all the more valuable to our clients.
I alone can do, whether because I am already easier. When clients can make a single call and
committed or I lack the necessary expertise. get what they need, that is easy. By sub- 3. Lighten your load
When a client reaches out to me with an contracting, my freelance business has a It is easy for successful freelancers to work
assignment, the first thing I do is assess whether reputation as a one-stop shop for all our clients’ themselves to the point of exhaustion. Face it, we
I am the right person for the job and, if so, medical writing and editing needs. As a result, love the challenge (and the money). But too
whether I have the bandwidth to take it on based our clients typically reach out to us first because much of a good thing can make us distracted, and

www.emwa.org Volume 28 Number 3 | Medical Writing September 2019 | 41

Subcontracting: Not for the faint of heart – Bass

distraction can impede our performance and from other freelancers, your Perhaps the best thing the US and around the world,
reduce the quality of our work. No matter how company can command and I have found that time
about subcontracting is
good we are, if important details start falling higher rates – but to a point, zones also work to our
through the cracks, those cracks create openings and this is where the that you can make advantage. As I am waking up
for other freelancers to step in. (Remember what difference between hourly money while you are in the eastern US, a writer on
I wrote at the start of this article about there and project pricing comes in. sleeping, vacationing, my team who resides in the
being a lot of people at the dance?) According to It is possible to build a UK already has 5 hours in on
caring for a sick child or
one MIT neuroscientist and expert on divided subcontracting model based the day. As I am leaving my
attention, multitasking is a myth.1 Despite what on hourly pricing. However, an ageing parent, or office at the end of the day, a
we think, our brains have very limited bandwidth there is a finite amount struggling with a writer on my team in
for processing new information. When we think clients are willing to pay per hurricane-induced California still has 3 hours to
we are multitasking, we are actually cognitively hour, so charging by the hour complete her assignment.
power outage.
switching very quickly between tasks, which restricts you to charging for When you subcontract, you can
reduces efficiency and quality and increases the time, not for value. Value is how make money all the time.
chance for errors. Subcontracting enables me to the subcontracting model works. Project pricing
keep myself from becoming overloaded (well, enables you to charge for the value of your 6. Build your business into an asset
usually), because I have other writers on my team service rather than for the time it takes to get Freelancers are entrepreneurs. The ultimate goal
whom I trust implicitly and with whom I can something done. This, in turn, enables you to of entrepreneurship is to build assets you can
divide the workload to conquer it all. pay your freelances well while still paying make money from for as long as you want, then
yourself. If you are not making money on the cash out by selling the business and move on.
4. Make more money work your subcontractors are doing for you, Most freelance medical writers are what I call a
There’s no disputing that freelancers love what is the point? “business of one”. They are the business and the
money. We work hard for it. And as successful business is them. That can make the business
freelancers know, you can earn much more 5. Make money while you sleep difficult (but not impossible) to sell, because the
money as a freelancer than anyone would ever The worst thing about freelancing is that you buyer has to be willing to then become the
pay you to work on staff. When you subcontract, don’t make money when you are not working. business, too, and the clients have to be happy
you have more people working hard for it, which Perhaps the best thing about subcontracting is with the new owner/freelancer. Also, it takes
means you have more money coming in. The that you can make money while you are sleeping, money to buy a business. I doubt someone
income from every project exceeds your out-of- vacationing, caring for a sick child or an ageing wanting to break into freelancing would be
pocket cost to the subcontractor, and that goes parent, or struggling with a hurricane-induced willing to risk the capital to “buy” another
directly to your bottom line. How much excess? power outage. I recently took a 3-week holiday, freelancer’s clients, which is something a
That is up to you, and up to what your market which is the longest time I have taken off in my successful freelancer would never have to do
and your clients will bear. What helps determine entire career. When I go on holiday, I don’t take anyway. A freelance medical writing business
what your clients and what your market will any work with me. No email, no teleconferences, with both clients and subcontractors is bigger
bear is the added value your company brings to no computer. Nothing. I work hard, so I play than the person who owns it, making it a more
the table compared to other freelancers. Value hard. While I was away, the subcontractors on attractive asset for an investor who might or
is intangible, but to your client it is palpable. my team were continuing to work on their might not also be a medical writer. Eventually,
When they get a level of quality, confidence, and projects. New projects were coming in the door selling the business could be an attractive option
efficiency from you and your subcontracting while others were being delivered. It’s for you to transition into retirement or start a new
team that is greater than what they feel they get wonderful! I work with subcontractors across venture.

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 Bass – Subcontracting: Not for the faint of heart

The disadvantages of right subcontractors, and When subcontracting, supports our outstanding
subcontracting managing the amount of time reputation as a business and
If subcontracting was easy, everyone would do it. and effort you spend on these
you can work harder our unique value as a business
It is not, and for a number of reasons. These are activities. And don’t forget, than you have ever partner.
what I think are the top five disadvantages of while you are managing all the worked before and
subcontracting: subcontractors, clients, and ultimately earn less for 3. Risk your cash flow
projects, you are also getting, From the client’s perspective,
1. Work harder and earn less estimating, writing, and
your time, effort, and a major advantage of hiring a
Subcontracting involves a lot of work that has managing your own projects! value than before you freelance medical writing
nothing to do with putting words on the page. A lot of what I described started subcontracting. business that subcontracts is
Imagine this: you have six subcontractors, each here may seem like project that they get access to a
of whom might be working with you on two management, and a project number of great writers and the
assignments. Each of those 12 assignments began manager would surely help. The ability to accomplish a number of
as opportunities, with phone calls or emails challenge is deciding the point at which it makes projects simultaneously, all through a single
requiring your attention and follow up. Each financial sense to bring someone onto the team supplier. No multiple master service agreements
project has to be estimated, which is a process on who costs money, but who does not generate or confidentiality/nondisclosure agreements, no
which I work very closely with the writer or money. However, the activities and responsi- multiple business entries for accounting. It may
editor who will be doing the work. After the bilities I have described are not all or only related even be easier for them at tax time. The reason for
estimate is submitted to the client there might be to project management. Along the way I am this is that their business relationship is with you,
some negotiation, then finalisation, and making decisions and commitments only the not with the subcontractors. This means that the
invariably paperwork to review and sign. Multiply business owner can make. subcontractors’ business relationships are with
that by 12. When possible, I want to be on every you, not with your clients. If a client becomes
call between the subcontractor and my client, so 2. Risk your reputation slow in paying, or worse yet tries to slip out
I know what is going on. Multiply that by 12. A key benchmark in the journey to becoming a without paying, that is not your subcontractor’s
My obligation is to the clients, to ensure they successful freelancer is the point at which your problem. You owe the subcontractor’s fee, and
receive the value they expect from their reputation in the field brings you more work than you owe them timely payment, regardless of what
investment in us, and to the subcontractors, to your traditional marketing efforts. It takes a lot of happens with your client. This can put quite a
ensure they get whatever they need to do the job time and effort to build a good reputation, and strain on cash flow if you don’t stay on top of your
to the level of quality our clients expect, and to no time at all to destroy it. When you sub- accounts receivable and make sure your clients
intercede if the project or the client goes off the contract, you grant to every subcontractor the pay on time.
rails. Multiply that by 12. While I prefer power to uphold or destroy your reputation.
subcontractors to have direct lines of com- Make no mistake, this is not just a big thing, it’s 4. Risk your exposure
munication with the client (always copying me), everything. I know many people who subcontract Freelancers are accustomed to signing confi-
I serve throughout the project as a sounding to new freelancers and novice medical writers. dentiality or nondisclosure agreements, ensuring
board for the subcontractor to bounce ideas, There’s nothing wrong with that. In fact, I admire any confidential information you receive in the
discuss their strategy and approach, review drafts, successful freelancers who not only mentor but course of doing business with your client will
and run interference when necessary. Multiply actually make mentoring a part of their business remain confidential. One could argue that as a
that by 12. model. A major benefit is that you can mould the business of one, you are in complete control and
Throughout the process I am fielding emails subcontractors in your unique style and ways. therefore there is little possibility of anything
and phone calls related to each project. I am A major drawback is that it’s a lot of work to turn going wrong or of you doing anything unethical.
receiving progress invoices from the sub- new writers into great writers and novice But when you have subcontractors working with
contractors and invoicing the clients, then freelancers into great freelancers. As I alluded to you, even though you presumably hire
receiving and processing payments and paying in the last section, the more time you spend professionals who know better, your company’s
the subcontractors. Multiply all that by 12. managing your subcontractors, the less money exposure to potential liability increases
The bottom line is that when subcontracting, goes to your bottom line. exponentially. As a freelance business, when you
you can work harder than you have ever worked I feel a personal as well as a professional sign a contract you sign for your company. If you
before and ultimately earn less for your time, commitment to mentoring new and aspiring use subcontractors, your signature on the
effort, and value than before you started medical writers and freelancers, and I do it often. contract includes taking responsibility for your
subcontracting. You have to be very careful about But when it comes to my business I want to hire subcontractors. That is a lot of responsibility. At
choosing the right subcontractors, choosing the only the most experienced and successful the start of any subcontracting relationship I ask
right clients for whom you will let subcontractors freelancers to work with me for the benefit of our the subcontractor to sign a nondisclosure
work (and some clients want only you, not a clients. This is how I ensure our clients agreement. It’s a simple agreement I have
subcontractor), marrying the right projects to the consistently get the very best work, which prepared based on many examples I have seen

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Subcontracting: Not for the faint of heart – Bass

and read over the years. It is not restrictive of l First and foremost, medical writers must an assignment due to COI, the client I am turning
trade, and it does not include one of those nasty always be acknowledged for their contri- away typically respects and values my ethical
indemnification clauses. My business also carries bution to a manuscript.2-4 position and comes back to me with other
general liability insurance and professional l Second, you should never work on competing opportunities in the future knowing I will be the
liability (errors and omissions) insurance. I did products in the same therapeutic area at the first to blow the whistle if a potential COI exists.
not bother with these when I was a business of same time.
one. The confidence I have in the professionalism l Third, if you work with medical comm- Tips to make subcontracting
and ethics of my team is now supported by the unications companies, you should never help work for you
nondisclosure agreement I have with each one client take business from another client. Just as freelancing is not right for everyone,
subcontractor and the insurances my company l Fourth, if you work in promotional areas and neither is subcontracting. I thought about it for a
carries. This gives our clients an added sense of also write continuing medical education, you long time before taking the plunge. I couldn’t
confidence and comfort when I sign their must observe ethical washout periods. figure out how it could possibly work. If I was
contracts on our collective behalf. charging at the top of what a freelance could
The ethical situations described above are charge, how could I possibly hire subcontractors
5. Increase potential conflicts straightforward. But when you subcontract, who were as good if not better than me, pay them
Conflict of interest (COI) is a fact of life for ethical conundrums can arise. For example, is it just as well, and convince clients to pay even
freelancers. The longer you work the more unethical to have one subcontractor working on more so there was money in it for me? Then I
therapeutic areas you work in; the more drugs, a project for a product that competes with remembered having a similar concern many years
devices, or diagnostic tests you write about; the another product on which you have a different before when I was contemplating quitting my
more clients and companies you work with; and subcontractor working on a project at the same perfectly good job and starting a freelance
the more likely you are to have to decline an time? Or, is it unethical to have one sub- business. Just as before, I couldn’t let fear and
opportunity due to COI. Now, multiply that risk contractor writing a branded promotional uncertainty stand in my way. My subcontracting
by the number of subcontractors on your team. PowerPoint presentation for a product at the journey has not been easy, but it has been
When you subcontract there is a much greater same time another subcontractor is writing a rewarding and fulfilling. I continue to learn new
likelihood that COI situations will arise, and you continuing medical education piece for the same things each day.
need to know how to handle them. These are a product? In my opinion, anything that even
few of the basic ethical principles to which all remotely gives the appearance of potential COI I will leave you with these 10 subcontracting tips
freelance medical writers should ascribe (this is is something to avoid. This also builds trust with to help you get started.
certainly not a complete list): your clients. In my experience, when I turn down

44 | September 2019 Medical Writing | Volume 28 Number 3

 Bass – Subcontracting: Not for the faint of heart

10 Subcontracting Tips
1. First, be successful. 4. Stay on top of everything. 8. Act like a business.
If you don’t already have a thriving Your job is to make sure both your client When you subcontract, clients expect you
freelance business, don’t start giving away and your subcontractor are getting what to act like a full-fledged business instead of
your work to subcontractors. Your success they need, and to keep things from getting a “business of one,” because you are!
comes first! out of hand. Projects move fast!
9. Be responsive.
2. Always be transparent. 5. Estimate carefully. The busier you get, the more vital it is that
Clients need to know who is working on When working with a subcontractor, you you respond quickly and thoughtfully to
their projects, and not all clients want you are estimating for two. Make sure there’s all emails and phone calls. Think you are
to use subcontractors. In time, your clients money in the project for everyone! busy now? Just wait!
will love your subcontractors so much
they will request them by name! 6. Maintain your visibility. 10. Own every mistake.
This is your company, your clients, your Errors don’t belong to the people on your
3. Don’t get in the way. team, and your reputation! team who make them, they belong to you.
Let your subcontractors have a direct line Learn from them fast!
of communication with your client, but 7. Know your limitations.
make sure you are always in the loop so Subcontracting gives you more capability,
BONUS TIP!
11. Be grateful.
you can support the team and the process. but it does not make you invincible. Don’t
Be the first to give credit to the people on
You are the value added! be afraid to say no!
your team for a great idea or a job well
done. Without the orchestra, a conductor
is just a person with a stick!

Acknowledgements References
The author would like to thank Cynthia L. 1. Miller EK. Multitasking: why your brain Author information
Kryder, MS, for her assistance in reviewing this can’t do it and what you should do about it. Brian Bass, MWC, is President of Bass
manuscript. [cited 2019 Jun 3]. https://radius.mit. Global, Inc.; co-author of The Accidental
edu/sites/default/files/images/ Medical Writer® series of books, resources,
Disclaimers Miller%20Multitasking% 202017. pdf. information, and inspiration for freelance
The opinions expressed in this article are the 2. Battisti WP, Wager E, Baltzer L, et al. Good medical writers; Past-President of The
author’s own and not necessarily shared by publication practice for communicating American Medical Writers Association
EMWA. company-sponsored medical research: (AMWA); and recipient of the 2017 Harold
GPP3. Ann Intern Med. 2015;163(6): Swanberg Distinguished Service Award for
Conflicts of interest 461–4. his contribution to the field of medical
The author declares no conflicts of interest. 3. No authors listed. Recommendations for communications.
the conduct, reporting, editing, and
publication of scholarly work in medical
journals. 2018 [cited 2019 Jun 5].
http://www.icmje.org/icmje-
recommendations.pdf.
4. AMWA-EMWA-ISMPP joint position
statement on the role of professional
medical writers. 2017 [cited 2019 Jun 5].
https://www.amwa.org/general/custom.
asp?page=Position_Statement.

www.emwa.org Volume 28 Number 3 | Medical Writing September 2019 | 45

Lay summaries and writing for
patients: Where are we now and
where are we going?
Lisa Chamberlain James1 and advocacy groups and the public in general. Some therapy area. Writing instead for an audience of
Trishna Bharadia2 information has always been available to patients, readers who may have a low level of health
of course. Information about a medicine’s side literacy and perhaps little or no disease and
1 Trilogy Writing and Consulting, England effects and how to reduce any associated risks is therapy area knowledge is a significant challenge.
2 Patient Engagement Consultant, given in the package leaflet that is supplied with This article looks at the challenges in writing
Ambassador for MS Society UK, ADD the medicine, and so most patients are aware of the RMP and CTR lay summaries from the
International and Lyfebulb, Patron for this – even if its usefulness has been questioned medical writing side and offers a viewpoint from
Huntingdon, Peterborough & Cambridge regularly.1–3 Other patient-specific information the patient’s perspective.
MS Therapy Centre, Patron for ParaDance is also available via the EMA website. The
UK, Patron for Chilterns MS Centre European Public Assessment Report summary Legislation and its challenges
explains how the EMA has assessed the benefits RMP (Rev 2) Section VI
and risks of a medicine before allowing it to be In March 2014, the EMA began publishing lay
Correspondence to: used. However, the availability of this informa- summaries of RMPs for centrally authorised
Dr Lisa Chamberlain James tion is perhaps less well known to the general medicines to explain and make more transparent
Trilogy Writing and Consulting Ltd. public, who are likely to be unfamiliar with the to the general public how the European
Merlin Place, Milton Road EMA website and may not instinctively know regulatory authorities make decisions about the
Cambridge. CB4 0DP how to navigate it. safety of medicines (the details of which have
+49 69 138 25280 The most recent changes to the legislation in been discussed previously).4,5 This was intended
[email protected] terms of information for patients and the lay to be a further step towards increased trans-
audience (the introduction of the lay summary parency and improved public access to
of the Risk Management Plan [RMP] and the lay information on medicines and was mandated by
Abstract summary of Clinical Trial Results [CTR]) have the European pharmacovigilance legislation
We examine the trend for increasing and caused great discussion and concern in an (Regulation (EU) No 1235/2010 and Directive
more transparent patient information and ask industry very willing to provide information to 2010/84/EU).
how close we have come in the last few years patients but more experienced with producing In March 2017, the guidance on drafting risk
to producing useful and meaningful complex scientific information for regulatory management plans was revised to make
information for patients. We also outline the authorities. RMP summaries describe how the significant changes to how lay summaries should
challenges faced by medical writers and the important risks of a medicine are being managed be written, which is given in part VI of the RMP.
pharmaceutical industry as a whole in trying or will be managed, and the CTR lay summary The guidance states that the audience for RMP
to comply with recent European require- explains the results of a clinical trial and what summaries is very broad, and that the
ments for the creation of lay summaries of key the sponsor believes they mean. However, summary should be ”written and
regulatory submission documents. The risk these documents can be challenging to write, presented clearly, using a plain-language
management plan and the results section and however much they are needed, this approach”.6 The 2017 changes also
describe outcomes of clinical trials – and what effort is wasted if they do not reach or connect removed the description of the efficacy
this means for patients – who are the target with their intended audience. Medical of the drug and the epidemiology
audience that this monumental effort is writers, who usually produce description.
intended to help. documentation for regulatory The revised (revision 2)
authorities, are highly trained guidance states that the
in a specific writing style lay summary should
“Patient-centricity” and “transparency” have and tone, and the usual contain information
been hot topics in the pharmaceutical industry audience for their work including safety con-
for the past few years. They are not new, but they consists of readers who cerns, risk minimis-
are increasingly important in the context of have a very high level of ation measures, and
regulatory documentation. Their implementa- health literacy and pharmacovigilance
tion has been supported by various official often a considerable activities. These
guidance documents and mandated by knowledge of the sections would not
legislation, much to the delight of patient specific disease or pose any difficulty for

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 Chamberlain James and Bharadia – Lay summaries and writing for patients

medical writers producing documentation for a EU CT Regulation), the EMA mandated that guidance on the European Commission website
regulatory authority. The problem, however, is clinical trial sponsors produce a summary of the in January 2017.16 This guidance gives example
conveying that information to a lay audience and results of every clinical trial in plain language text and formatting, which, although not perfect,
particularly to those with difficulty reading. In the (language that is understandable to the lay are certainly helpful. The updated guidance also
UK for example, 16% of adults (7.1 million audience) no later than 1 year after the end of the suggests more lay-friendly headings and a
people) are functionally illiterate. This means that trial in the EU.9-12 These CTR lay summaries will question-and-answer format. It allows the
they can understand short, straightforward texts be made available in a new EU database once it medical writer to add subheadings and change
on familiar topics, but have problems reading becomes available. the order of the headings, both of which can help
information from unfamiliar sources or on This requirement had originally been planned readers more easily understand and navigate the
unfamiliar topics.7 Considering that the average to take effect in 2018, but the creation of the document. Visuals and infographics are also
reading age in the UK is 11 years,8 the challenge database and upload portal was delayed, and so mentioned in the guidance, but care should be
of explaining the risks and harms becomes it is likely that it will not be implemented before taken with any graphics, since they do not always
apparent. 2020. In the meantime, many pharmaceutical increase comprehension.17 However, they may
These discussions are also often supported by companies are making the documents available make the CTR lay summary more user-friendly,
statistical information. Simply providing these to the general public via their own company and if used appropriately can be a powerful tool
numbers is not sufficient for the lay audience – website (e.g., UCB13 and Boehringer Ingelheim).14 to help understanding.
an understanding of what the numbers mean Despite the challenges involved in writing for
must also be conveyed, so that the risks, benefits, a lay audience, the introduction of CTR EU No Variable quality of existing
and incidence/prevalence can be put into 536/2014 has been seen as a welcome patient information
context. Additionally, the removal of the efficacy opportunity for the pharmaceutical industry to Given the relative newness of CTR and RMP lay
and epidemiology sections, although simplifying deliver clinical study results to the general public summaries and the lack of a general standard
the lay summary for the medical writer to – and especially to patients. A global survey in against which quality can be assessed, it is not
produce, makes it very difficult for the reader to 2017 showed that 91% of the general public surprising that the quality of current offerings
understand the benefits of the drug and the wants to receive a summary of a study after they varies considerably.
impact of the disease in general. had taken part,15 and so the information would We conducted an online search for CTR lay
appear to be wanted and needed by the general summaries, which returned several pharm-
Clinical Trial Regulation (CTR) EU public. However, there is a danger that this ceutical company web pages that contain lay
536/2014 opportunity will be wasted because writing for summaries of trials that they have sponsored.
In 2014, as part of its clinical trial transparency the lay audience is very challenging. Whilst some use graphics and tables to an extent,
initiative, in the EU CTR 536/2014 (Article 37 To address this, the EU provided further most still contain too much text; tools such as

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Lay summaries and writing for patients – Chamberlain James and Bharadia

bullet points and lists, which would make the What do patients really listing both generic and brand names where
document easier to read, are underused. One want and need? possible.21 If the brand name is not or cannot be
company’s lay summaries contained only text and Putting aside legislative requirements, the quality used, providing signposts to where the reader can
whilst the summaries were only about a page of a lay summary can be benchmarked against find that information is necessary. The same
long, they were incredibly difficult to read and whether it meets what a patient wants and needs. applies to explanations of medical terminology.
understand. In addition, even where companies What industry and clinicians think a patient Listing “high blood pressure” with “hyper-
used graphics, charts, and tables, sometimes they wants can be different from the reality, especially tension” in parenthesis would be a better way to
would have been better employed for different when it comes to patient input into their own describe this adverse event than simply listing
content within the document. healthcare.18 If lay summaries are to be fit for hypertension on its own. It means that the
Generally, the content found in the sum- purpose, they need to be understandable, document is still understandable but can also
maries appeared to be relevant for a lay audience. relevant, and accessible. help to educate and improve health literacy.
However, it was difficult to assess whether all As already discussed, the use of graphics can
useful information from the original document Understandability enhance a lay summary to a certain extent. It is
was included. The best summaries answered the It is important to avoid over-simplifying also important to ascertain what are suitable data
following questions for any potential patient information to the point of losing the for translation into an infographic, chart, or table,
reading the document: opportunity to educate patients or a lay audience and what formats are most likely to be under-
l “Is this trial relevant to me?” about a particular disease area or intervention. stood by readers. In a user-testing study on CTR
l “How would this intervention be admin- These documents have the potential to be key lay summaries, one participant asked why a
istered and monitored?” decision-making tools – an informed patient certain bar chart was “upside down”, demon-
l “Can I fully assess the risks and benefits of this often makes different choices about their strating that some figure formats may be
intervention?” healthcare.19 With an ever-increasing importance confusing to someone not used to them.22
l “Will this intervention be available to me in being placed on shared-decision making,20 Formatting of the lay summary is also important,
the future and what will it mean for me?” patients are increasingly looking towards lay with accessibility standards such as font size,
l “Where do I go for further information?” summaries to help inform their healthcare colour, use of bullet points, and layout requiring
Good examples of lay summaries also provide journey. A lay summary that directs the reader some consideration to improve comprehension.
background information and explanation of the towards a discussion with their clinician can
disease in question and the type of trial taking support this. We need to find the middle ground Relevance
place. However, currently only some do this, between a lay summary being simplified so much As a decision-making and educational tool, the
possibly assuming that patients would already that it loses its educational value and it not being lay summary needs to be relevant. The content
have basic knowledge in these areas. simple enough for a patient to digest the should be useful for the intended audience, not
What is clear is that that a systematic and information without the help of a qualified just what the sponsor wants to convey. For a
comprehensive review of the current offerings is medical professional. patient who is considering a new intervention,
needed to fully gauge what is being done well and Another important aspect is for the lay the risk-benefit profile is likely to be a top
where improvements are required. summary to use words that are familiar to a lay concern. However, there are other factors that
audience. One such example is the use of brand patients consider to be important and which the
names for medications. Some guidelines suggest lay summary can and should include so that an

48 | September 2019 Medical Writing | Volume 28 Number 3

 Chamberlain James and Bharadia – Lay summaries and writing for patients

Finally, whilst there are already plans for a content, and readability. A patient by experience
single upload portal for lay summaries, it is of the could review a lay summary for readability and
utmost importance that this is widely advertised how well it might be understood by a lay
to lay audiences generally and to patients audience, whereas expert and pro-patients would
specifically. This should be done via as many be more suitable to assess relevance of content.
different channels as possible – via healthcare This is because those tasks would require a much
professionals, national healthcare systems (e.g., higher level of health literacy and, potentially, the
the NHS website), charities and patient ability to understand the original clinical trial
associations, and the sponsors’ own website. documentation from which the lay summary has
Participants in particular trials should also be been produced. It can also be beneficial to involve
informed of the availability of a lay summary of patients in developing lay summaries that do not
results. In addition, a single portal should not cover their particular disease area. This is because
necessarily be the only place where lay patients may be in danger of becoming “too
summaries are published. If they are published in expert” or “too comfortable” in their own disease
multiple locations, such as through the sponsor’s area to consider the document from a lay
website, via academic-sponsored sites, or through perspective.
relevant research events, they are more likely to
be seen. A discussion of the relative advantages User-testing for readability
overall assessment can be made. These include and disadvantages of dissemination via different There has been much discussion about whether
who took part in the trial (to assess applicability sources can be found in lay summary imple- readability tools are suitable for assessing health
to the reader); the mode of intervention (e.g., was mentation guidelines published by TransCelerate information. The Patient Information Forum
the treatment administered orally, via IV Biopharma.25 points out that these tools only assess language
infusion, via injection, etc.); the frequency of and do not consider design, layout, structure, or
intervention, and any monitoring requirements. Involving patients in the the tone of information. In addition, different
These can all have an impact on a patient’s production of lay summaries readability tools can often produce different
decision to pursue a certain intervention, There are many guidance documents for lay reading levels and scores when applied to the
whether that is within further clinical trial summaries that suggest the involvement of same text.27 Having end users assess the
settings or once the drug is licensed and available. patients in their production. How this involve- readability of a lay summary is not only an
Following on from this is the benefit of ment would work, however, is not outlined as obvious choice but is also both feasible and can
including an explanation of the stage in the clearly, indicating that there is a need for best be highly successful, as evidenced by the
development process the lay summary relates to. practice to be shared and a standard to be set. The Production of Lay Summaries for the Newcastle
This could be a marker on a timeline or a “What Roadmap Initiative to Good Lay Summary Cognitive Function after Stroke Cohort Study.28
does this mean for me?” section. It will help the Practices26 could be a step towards this. Initially, organisations may be put off from
reader to understand whether the intervention involving patients, due to cost and the possibility
will be available imminently or not. The general Not all patients are the same of having to train external collaborators. Training
public, and many patients, are unaware of the Any type of engagement with patients can be made easier with the use of available
complexities and timelines of the drugs necessitates the reminder that not all patients are toolkits, such as the one co-produced by Envision
development process. Presenting them with a the same. “Patients by experience” and “expert Pharma, and multiple stakeholders.29 It offers a
document that, for example, talks about a patients” are terms that are now widely used template to provide patient reviewers with key
positive Phase 2 trial, could result in misguided within healthcare settings. However, there is also information so that the lay summary can be put
belief that they will be able to go to their doctor the emergence of the so-called “pro-patient”. into context and the review process made easier.
and ask to be prescribed the drug. These are patients who look at the overarching The cost of involving patients in the process
issues and systemic issues that cross over patient should be offset against the added value that they
Accessibility communities. They are often well-connected will bring to producing a high quality, fit-for-
Once published, lay summaries need to be with various stakeholders and have a high level of purpose document. In the future, this cost needs
accessible, i.e., they need to be easy to find and health literacy, even outside of their own disease to be considered as integral and necessary to the
available to all. Open access sources are critical area. When involving patients in the develop- budget as the cost of involving a medical writer.
for this so that the lay reader is not blocked by a ment of lay summaries, we should bear in mind Lay summary development cannot progress
paywall. It is incredibly frustrating when a patient that each group of patients will be able to bring without the involvement of the patient. As
finds information, only to discover they are different value and expertise to the process and, standard operating procedures for processing lay
unable to access it. Some sponsors already use an therefore, may only be suitable for involvement summaries are developed and templates for
open-access model and mandate that all affiliated at certain points. producing content are created, patients need to
research must be published in open access Patients could potentially become involved by be constantly considered. Ultimately, patients
sources.23,24 reviewing the lay summary for relevance of will be the primary end user of this document

www.emwa.org Volume 28 Number 3 | Medical Writing September 2019 | 49

Lay summaries and writing for patients – Chamberlain James and Bharadia

and involving them in the process will be key to

it becoming less of a “box ticking” exercise and
more of an exercise in producing good quality,
relevant health information that can help people
to make better decisions about their healthcare.

Conclusion
The latest regulations and the drive for trans-
parency and patient engagement require us to
present data and messages in a way that the lay
audience can both understand and use. It is a
huge challenge and requires a medical writing
skill set different from that used to present data
to regulatory authorities. Writing in lay language
is far more than just translating clinical words into
simpler ones, and it is crucial that we reach out
to our audience, either through user testing or
through engagement with patient advocacy
groups, to allow us to understand what they really 3. Piñero-López MÁ, Figueiredo-Escribá C, 10. European Medicines Agency (EMA).
want and need. Modamio P, Lastra CF, Mariño EL. Summaries of clinical trial results for
What is clear is that this drive for clearer and Readability assessment of package leaflets laypersons. UK: EMA. 2018 [cited 2018
better information for the lay audience is not of biosimilars. BMJ Open. 2019;9(1): Mar 12]. Available from:
decreasing but is most certainly gaining in e024837. https://ec.europa.eu/health/sites/health/
momentum, and this is being acknowledged in 4. Chamberlain James L, Creuwels LAJM, files/files/eudralex/vol-10/2017_01_26_
the latest regulations and guidance. In a survey of Davies M. Risk management plans – new summaries_of_ct_results_for_laypersons.
adult internet users, 83% looked online for health challenges for a new era. Reg Rapp 2014; pdf.
information, and 60% said that it had an impact 11(6):4–7. 11. Thomas KB. Clinical trial disclosure and
on their decisions or actions.30,31 This means that 5. Prechtel K, Rechtsteiner S. Medical writing transparency: Regulation EU No.
the quality of health information available to for two audiences – The RMP public 536/2014 Public disclosure at the clinical
patients is a major concern and increasingly summary. Med Writ 2015;24(4):200–4. trial level. Med Writ. 2018;27(2):7–17.
important. Medical writers are the gatekeepers 6. Guideline on good pharmacovigilance 12. Sroka-Saidi K, Boggetti B, Schindler TM.
for this information, and we should certainly practices (GVP) Module V – Risk Transferring regulation into practice:
welcome the trend for increased information to management systems (Rev 2) 28 March The challenges of the new layperson
patients – as long as it is in a form that is helpful 2017 EMA/838713/2011 Rev 2*. summary of clinical trial results. Med Writ.
and fit for purpose. 7. Adult literacy [cited 2019 May 16]. 2015;24(1):24–7.
Available from: https://literacytrust.org. 13. Study results - lay summaries [cited 2019
Acknowledgements uk/parents-and-families/adult-literacy/. May 16]. Available from:
The author acknowledges the help and advice of 8. Why reading age is a key factor in https://www.ucb.com/our-science/
Dr Barry Drees, Trilogy Writing, in the successful eLearning design [cited 2019 Our-clinical-studies/Study-Results-Lay-
preparation of this manuscript. May 16]. Available from: Summaries.
http://www.aurionlearning.com/online- 14. Lay summaries and lay summary videos
Conflicts of interest training-and-development-blog/2018/ [cited 2019 May 6]. Available from:
The authors declare no conflicts of interest. june/why-reading-age-is-a-key-factor-in- https://trials.boehringer-ingelheim.
successful-elearning-design. com/trial_results/clinical_trials_overview
References 9. European Medicines Agency (EMA). /clinical_trial_result.c=n.i=.html?
1. Pires C, Vigário M, Cavaco A. Readability Regulation (EU) No 536/2014 of the document_type=2.
of medicinal package leaflets: a systematic European Parliament and of the Council of 15. The Centre for Information and Study on
review. Rev Saude Publica. 2015;49:4. 16 April 2014 on clinical trials on medicinal Clinical Research Participation. Public and
2. Piñero-López MÁ, Modamio P, Lastra CF, products for human use, and repealing Patient Perceptions and Insights Study.
Mariño EL. Readability analysis of the Directive 2001/20/EC. UK: EMA. 2014 Boston: CISCRP. [cited 2018 Mar 12].
package leaflets for biological medicines [cited 2018 March 12]. Available from: Available from: https://www.ciscrp.org/
available on the internet between 2007 and https://ec.europa.eu/health/sites/health/ services/research-services/public-and-
2013: An analytical longitudinal study. J files/files/eudralex/vol-1/reg_2014_536/ patient-perceptions-insights-study/.
Med Internet Res. 2016 May 25;18(5):e100. reg_2014_536_en. pdf.

50 | September 2019 Medical Writing | Volume 28 Number 3

 Chamberlain James and Bharadia – Lay summaries and writing for patients

(COGFAST) study. Res Involv Engagem.

2017;3:18.
29. Plain Language Summaries (PLS) of
Publications Toolkit [cited 2019 May 18].
Available from:
https://www.envisionthepatient.com/
plstoolkit/.
30. The Social Life of Health Information
[cited 2019 May 28]. Available from:
https://www.pewinternet.org/wp-
content/uploads/sites/9/media/Files/
Reports/2009/PIP_Health_2009.pdf.
31. Do patients search for online health
information? [cited 2019 May 16].
Available from: https://trialfacts.com/
do-patients-search-for-online-health-
information/.

16. Summaries of clinical trial results for 23. Ipsen commits to making all its published
laypersons [cited 2019 May 28]. Available scientific research freely accessible to
from: https://ec.europa.eu/health/sites/ everyone [cited 2019 May 28]. Available Author information
health/files/files/eudralex/vol-10/ from: https://www.ipsen.com/ipsen- Lisa Chamberlain James is a Senior Partner
2017_01_26_summaries_of_ct_ commits-to-making-all-its-published- of Trilogy Writing & Consulting and has a
results_for_laypersons.pdf. scientific-research-freely-accessible-to-ever special interest in drug safety and patient
17. Buljan I, Malički M, Wager E, Puljak L, yone/. information. She has experience of both
Hren D, Kellie F, et al. No difference in 24. Shire Continues to Uphold High Standards communications and regulatory medical
knowledge obtained from infographic or of Ethics and Transparency with Adoption writing, and also runs and assesses workshops
plain language summary of a Cochrane of Open Access Policy for Publication of for EMWA. Lisa is a member of EMWA’s
systematic review: three randomized Shire-Supported Research [cited May 2019 Educational Committee, PV Special Interest
controlled trials. J Clin Epidemiol. May 18]. Available from: Group, Med Comm Special Interest Group,
2017;pii:S0895–4356(17)30490–0. https://www.shire.com/en/newsroom/ a Fellow of the Royal Society of Medicine,
18. Say RE, Thomson R. The importance of 2018/january/xajhds. and editor of the Medical Communications
patient preferences in treatment decisions - 25. Layperson Summaries of Clinical Trials: and Writing for Patients section of Medical
challenges for doctors. An Implementation Guide [cited 2019 May Writing.
BMJ. 2003;327(7414):542–5. 18]. Available from:
19. Patients’ preferences matter. Stop the silent http://www.transceleratebiopharmainc. Trishna Bharadia is a multi-award winning
misdiagnosis [cited May 2019 May 18]. com/wp-content/uploads/2017/02/ international health advocate and patient
Available from: https://www.kingsfund. Implementation-Recommendations_ engagement champion. She lives with several
org.uk/sites/default/files/field/field_ 20Jan17_Final.docx. chronic illnesses, including multiple sclerosis.
publication_file/patients-preferences- 26. Roadmap Initiative to Good Lay Summary She writes for various publications and is an
matter-may-2012.pdf. Practices Meeting [cited 2019 May 25]. advisor to industry, academic institutions, and
20. Shared decision making [cited 2019 May Available from: https://www.eupati.eu/ the third sector on health related and patient
18]. Available from: https://www.england. blog/roadmap-initiative-to-good-lay- engagement issues. She regularly speaks at
nhs.uk/shared-decision-making/. summary-practices-meeting/. events and conferences and in the media and
21. MRCT Tool kit [cited 2019 May 18]. 27. Guide to appraising health information is also involved in the co-production of
Available from: https://mrctcenter.org/ [cited 2019 May 25]. Available from: information and services, including plain
wp-content/uploads/2017/12/2017-12- https://www.pifonline.org.uk/wp- language summaries. She is a patron/
07-MRCT-Return-of-Aggregate-Results- content/uploads/2014/11/PIF-Guide- ambassador for several health- and disability-
Toolkit-3.1.pdf. Appraising-Health-Information-2010.pdf. related organisations, including MS Society
22. Clinical trial results summary for 28. Barnfield S, Pitts AC, Kalaria R, Allan UK, Lyfebulb, ADD International, and
laypersons: A user testing study [cited 2019 L, Tullo E. “Is all the stuff about neurons Chilterns MS Centre. She is also a Patient
May 18]. Available from: http://luto.co.uk/ necessary?” The development of lay Expert Partner of Admedicum, a patient
news/clinical-trial-results-summary-for- summaries to disseminate findings from the engagement firm.
laypersons-a-user-testing-study/. Newcastle Cognitive Function after Stroke

www.emwa.org Volume 28 Number 3 | Medical Writing September 2019 | 51

Clinical trial disclosure:
Perspective from a medical writer for a
contract research organisation
Vivien Fagan postings were intermittent and fluctuated in Clinical trial disclosure
IQVIA™, The Alba Campus, Rosebank, number. With the implementation of mandatory EMWA played a big part in my leap into the
Livingston, West Lothian, UK posting to the EMA’s European Clinical Trials world of disclosure, starting with the 2014
Database (EudraCT) of interventional clinical conference in Budapest, which attracted my
trials that ended on or after July 21, 2014, the attention with the 1-day symposium “Trans-
Correspondence to: impact was almost immediate: we saw a huge parency of Clinical Trial Data – Where Does
Vivien Fagan increase in the number of current and new clients Medical Writing Fit In?”. It was the start of a
Director, Global Medical Writing reaching out to ask if we could support this special relationship with a group of fellow
IQVIA activity. EMWA members, some of whom I already knew
The Alba Campus The article is a summary of how, as a medical through our years in the industry. I am talking
Rosebank, Livingston writer with over 20 years of experience, all with about the Budapest Working Group (BWG) –
West Lothian a CRO, I made the transition into the world of the EMWA-AMWA developers of CORE
EH54 7EG disclosure. (Clarity and Openness in Reporting: E3-based)
United Kingdom
+44 1506 814079
[email protected]

Abstract
In this article, I summarise how, as a medical
writer with over 20 years of experience in
regulatory writing, all with a contract research As a medical writer
organisation, I transitioned into the world of
disclosure and how I now have my feet firmly
working for a
in both camps: regulatory medical writing contract research
and clinical trial disclosure. I describe how organisation, these
disclosure captured my attention and the regulations have
subsequent actions I have taken.
had a considerable
but positive impact
Background on my day-to-day
Clinical trial transparency and clinical trial activities.
disclosure are terms that we are now all familiar
with, and it is not just pharmaceutical companies
that are under increasing pressure to make
clinical trial data that has not traditionally been
disclosed available to the public; any research
group that registers a trial must comply with the
same regulations.1-4
As a medical writer working for a contract
research organisation (CRO), these regulations
have had a considerable but positive impact on
my day-to-day activities. While our Global
Regulatory Affairs group has been supporting
our clients in their clinical transparency efforts
since 2008 and the release of the Food and Drug
Administration Amendments Act (FDAAA
801), requests to prepare clinical trial results

52 | September 2019 Medical Writing | Volume 28 Number 3

 Fagan – Clinical trial disclosure: A CRO medical writer’s perspective

Reference (www.core-reference.org). I returned “disclosure specialist”. The sole purpose of this suit part-time employees. This worked in our
from Budapest a member of the BWG and full of group was to perform disclosure activities, and favour and over the past 4 years this group has
ideas and insights for how our medical writing the first two members of this group (including grown.
group could provide support in the area of me) were medical writers by trade. We worked We also invested in our own software solution
transparency to our clients, old and new. Medical hard to learn the relevant regulations, taking to facilitate the creation, review, and upload of
writers are ideally suited to working in results advantage of all the training resources that are clinical trial results postings to EudraCT and
disclosure; we already have the skills that enable freely available through ClinicalTrials.gov and ClinicalTrials.gov. This has proved fruitful for
us to summarise clinical trial data and present the EudraCT.5,6 dual postings, where the clinical trial results are
results to address the objectives of a particular We continued to grow our dedicated required to be posted to both EudraCT and
study. In addition, we are renowned for our disclosure group by enticing other medical ClinicalTrials.gov, as the software tool avoids the
attention to detail. I know I am not the only writers who were perhaps looking for diversity or need for duplicate data entry. In addition, for
medical writer who cannot help but “edit” even part-time work/reduced hours per week. EudraCT postings where the sponsor does not
everything I read, from newspaper articles to Our aim was to engage a couple of candidates have a primary results user, the EMA can take up
printed works of fiction! who could prepare the postings while supporting to 25 calendar days to process a EudraCT access
I spent many hours getting up to speed on the each other on their out-of-office days. Preparing request, and sometimes impending registry
regulations for the USA and EU/EEA. By the a clinical trial results posting takes much less time deadlines do not afford the luxury of time. Our
end of 2014, we had established a clinical trial than, for example, preparing a clinical study software tool allows us to initiate the results
disclosure group in the UK along with the role of report (CSR), and this effort can be moulded to posting and to download drafts for sponsor
review. We can then upload the entry to EudraCT
as an XML file7 when we get access.

Clinical trial results postings

Our daily tasks include the prepa-
ration of both EudraCT and
ClinicalTrials. gov postings and,
more recently, review of the
study protocol, applicable
protocol amendments, and the
statistical analysis plan for any
information requiring redaction
before submission to ClinicalTrials.
gov.3
As is typical in a CRO, levels of requests for
our disclosure services can fluctuate. Following
publication of the EU Trials Tracker8 (which
lists, by sponsor, all interventional clinical trials
in the EU Clinical Trials Register), we noticed a
surge in requests from clients. Although not built
or monitored by the EMA, the EMA have been
using the tracker to reach out to sponsor
companies directly, using the last known contact
information from the EU Clinical Trials Register,
to inform them that they either:
a. Have results due, i.e., it has been more than
1 year since the “global end of trial date”; or
b. Have inconsistent data, i.e., the sites where the
trial was conducted have listed their status as
“completed” but there is no accompanying
“global end of trial date”; there is a “global end
of trial date” but some sites are listed as
“ongoing”; or the trial status is blank.

www.emwa.org Volume 28 Number 3 | Medical Writing September 2019 | 53

Clinical trial disclosure: A CRO medical writer’s perspective – Fagan

Where the EMA has been successful in are disclosure-ready for any submission packages, bank of medical writers trained in the preparation
reaching the appropriate sponsor contacts, there but also ensures that – right from the outset with of clinical trial results postings. It is clear that
has been much surprise as to the number of the protocol – medical writers are thinking about medical writers have the skills required to
sponsor studies currently without results in results disclosure. competently complete the tabulated data
EudraCT. postings in EudraCT and ClinicalTrials.gov: We
The same group who put together the EU For example: have the ability to understand the design of a
Trials Tracker (Evidence-Based Medicine Data l Both the protocol and CSR should contain study and why it was performed; to understand
Lab, University of Oxford) have also created the only the necessary confidential information what the objectives were and what the resulting
FDAAA Trials Tracker9 (which lists, by sponsor, regarding the compound under investigation endpoint results show; to extract the data that
all applicable clinical trials and probable clinical or the people involved in the trial (for should be included; and to appropriately
trials, where an applicable clinical trial is a trial example, avoid the inclusion of investigator or summarise text within the character limits set by
that began after January 18, 2017, and a probable vendor names, centre IDs, subject-specific the database.
clinical trial is a trial that began before and ended information, and proprietary information, Clinical trial disclosure offers the opportunity
after January 18, 2017). Note: the FDA itself is where possible). to operate in an evolving environment and to
not publicly tracking compliance. l Within the ClinicalTrials.gov Protocol become an expert in the evolving requirements
I predict that we will see the effect of these Registration and Results System, there is a and regulations. You get to use your practical
trackers for some time to come as increasing 600‑character limit for the “official title” of the experience in working with clinical trial data to
numbers of sponsor companies become aware of trial. help your customers understand and meet their
the trackers and can access them to see where l Within EudraCT and ClinicalTrials.gov, there obligations.
they are non-compliant. is a 255-character limit for an outcome
measure title. Acknowledgements
Clinical trial disclosure in a CRO l Outcome measures should include the The author would like to thank Christine Lee
As is typical for a CRO, we are exposed to a wide measure, units, and time points. Haggard (IQVIA) who provided helpful
variety of clinical trial results data, both in terms comments and insight.
of phase and therapeutic area. No two studies are My role as head of clinical trial disclosure
the same and, combined with the challenges of To help me in my role leading this group, I am a Disclaimers
working in regulated databases with restrictions, member of DIA and associated medical writing The opinions expressed in this article are the
character limits, and required verification steps, and clinical trial transparency community author’s own and not necessarily shared by her
this means that preparation of clinical trial results groups. The BWG published CORE Reference in employer, EMWA, or other members of the
postings is anything but routine. All this can keep May 201610 and we remain engaged in supp- BWG.
even the most challenge-hungry individual orting the global medical writing community in
satisfied. fulfilment of reporting obligations that take full Conflicts of interest
This is a moving landscape and our group account of transparency and disclosure require- The author declares no conflicts of interest.
continually monitors industry and regulatory ments.11 I am an EMWA workshop leader on
agency changes. We do this in several ways, CORE Reference and was a panel member on References
including by signing up to notifications and blogs this topic at the DIA 2017 Global Annual 1. Official Journal of the European Union.
from the FDA (https://www.clinicaltrials.gov/ Meeting (Driving International Awareness and Commission Guideline – Guidance on
ct2/resources/rss) and EMA (https://eudract. Use of Regulatory Writing Guidelines: Case posting and publication of result-related
ema.europa.eu/), attending webinars hosted on Studies of the Clarity and Openness in Report- information on clinical trials in relation to
their public sites, and using other online training ing:E3-based [CORE] Reference Guidelines). the implementation of Article 57(2) of
resources provided by both agencies. We share Regulation (EC) No 726/2004 and Article
lessons learned within our group and in the Conclusion 41(2) of Regulation (EC) No 1901/2006.
broader field of disclosure through forums such I feel very lucky to have been able to play a pivotal (2012/C 302/03). 2012 [cited 2019 Jun
as the Drug Information Association (DIA). role in the creation and subsequent growth of our 13]. Available from: https://ec.europa.eu/
Internally, our disclosure specialists have in-house clinical trial disclosure group by health/sites/health/files/files/eudralex/vo
worked with our medical writers to make engaging in activities such as hiring staff, l-10/2012_302-03/2012_302-03_en.pdf.
changes to the protocol and CSR Clinical establishing processes and standard 2. U.S. Food and Drug Administration. Food
templates to take account of trial disclosure offers operating procedures, and and Drug Administration Amendments Act
data transparency. This not
the opportunity to operate developing job descriptions (FDAAA) of 2007, Pub. L. No. 110-85, 121
only helps our global and job grades. Stat. 823. Section 801. Expanded clinical
medical writers ensure in an evolving environment and As well as our trial registry data bank. 2007 [cited 2019
that they can provide to become an expert in the evolving disclosure specialists, we Jun 13]. Available from: https://www.fda.
sponsors with CSRs that requirements and regulations. also have an additional gov/science-research/clinical-trials-and-

54 | September 2019 Medical Writing | Volume 28 Number 3

 Fagan – Clinical trial disclosure: A CRO medical writer’s perspective

This is a moving
landscape and our
group continually
monitors industry and
regulatory agency
changes.

human-subject-protection/fdas-role- EudraCT training – training environment. 2016 [cited 2019 Jun 13]. Available from:
clinicaltrialsgov-information. 2019 [cited 2019 Jun 13]. Available from: http://www.core-reference.org/.
3. Federal Register. Department of Health https://eudract-training.ema.europa.eu/. 11. Review of the TransCelerate template for
and Human Services. Clinical Trials 6. Clinicaltrials.gov. Protocol Registration and clinical study reports (CSRs) by the
Registration and Results Information Results System (PRS). 2019 [cited 2019 developers of CORE Reference (Clarity
Submission; Final Rule, 42 CFR Part 11. Jun 13]. Available from: and Openness in Reporting: E3-based).
2016 [cited 2019 Jun 13]. Available from: https://prstest.nlm.nih.gov/. 2019 [cited 2019 Aug 06]. Available from:
https://www.federalregister.gov/document 7. European Medicines Agency. EudraCT https://rdcu.be/bM7f H.
s/2016/09/21/2016-22129/clinical-trials- Public website. Results documentation/
registration-and-results-information- XML schemas and documentation. 2019
submission. [cited 2019 Jun 13]. Available from:
4. European Medicines Agency. External https://eudract.ema.europa.eu/result.html.
guidance on the implementation of the 8. Evidence-Based Medicine Data Lab,
European Medicines Agency policy on the University of Oxford. EU Trials Tracker.
publication of clinical data for medicinal Who’s not sharing EU clinical trial results?
products for human use. 2018 [cited 2019 Jun 13]. Available from: Author information
EMA/90915/2016 Version 1.4. 2018 http://eu.trialstracker.net/. Vivien Fagan has over 23 years of experience
[cited 2019 Jun 13]. Available from: 9. Evidence-Based Medicine Data Lab, in an international CRO. In her current
https://www.ema.europa.eu/en/human- University of Oxford. FDAAA position as Director, Medical Writing, she
regulatory/marketing-authorisation/ TrialsTracker. Who’s sharing their clinical manages IQVIA’s medical writing group
clinical-data-publication/support- trial results? 2019 [cited 2019 Jun 13]. based in Livingston, Scotland, whilst heading
industry/external-guidance- Available from: up the global clinical trial disclosure group.
implementation-european-medicines- http://fdaaa.trialstracker.net/. Vivien is an EMWA workshop leader and has
agency-policy-publication-clinical-data. 10. EMWA-AMWA. CORE Reference (Clarity been a DIA panellist.
5. European Clinical Trials Database. and Openness in Reporting: E3-based).

www.emwa.org Volume 28 Number 3 | Medical Writing September 2019 | 55

The 360° approach to authoring risk
management plans
Sushma Materla During the drug development process, the top authority questions. This article is meant to serve
Aixial, Paris, France priority at any stage for every stakeholder is an overview of the topic, designed to provide
patient safety. While there are numerous insights about a holistic, “360°” approach for
regulations by different health authorities (HAs), RMP development rather than serving as
Correspondence to: the Risk Management Plan (RMP) introduced detailed template training.
Sushma Materla by European Medicines Agency (EMA) in 2007
Aixial, 3 Avenue de la Cristallerie is considered to be one of the best examples of Essence of a risk
92310 Sèvres – France “good pharmacovigilance practices” (GVP) to management plan
+33 6 22 45 51 58 ensure patients’ safety. Since then, this pharma- Not just a regulatory document!
[email protected] covigilance (PV) system has mandated the An RMP is a comprehensive document that
development of an effective safety plan for every details the safety profile of a product, a PV plan
marketed product right from the first marketing for collecting additional safety and efficacy data,
Abstract authorisation application (MAA) to as long and measures to mitigate safety concerns
Amidst the dynamic landscape of pharma- as it available in the market. An RMP The associated with the product’s use.
covigilance legislation, medical writers have has been demonstrated as one of Additionally, it provides all the
been gaining increased visibility and the most effective PV tools and
GVP Module V commitments of a marketing
importance beyond what had been their a key turning point for global switched the entire authorisation holder (MAH)
traditional role of coordinating and facilit- PV regulatory practices. The perspective of risk on further plans to evaluate
ating the development of risk management GVP Module V switched management approach from the effectiveness of risk-
plans. Over the past couple of years, medical the entire perspective of risk minimisation measures for
writers have been contributing extensively in management approach from
“spontaneous reactive” to managing patients’ safety.1
driving the seamless integration of the recent “spontaneous reactive” to “continuous proactive” in It forms a part of
Good Pharmacovigilance Practices guidance “continuous proactive” in dealing with patients’ the Common Technical
version 2.0 into companies’ global pharma- dealing with patients’ safety. safety. Document (CTD) Module
covigilance systems, quality assurance systems, Unlike other regulatory docu- 1.8.2. It is not just a regulatory
and relevant standard operating procedures. ments, the process of RMP development document or a regular safety report but
A comprehensive “360°” approach adapted by is unique and elaborate, and the medical writer also a legally binding administrative document
medical writers ensures efficient authoring of (MW) plays a significant role in efficient with monetary implications. Since 2014, the key
high-quality RMPs. authoring of RMP. This article highlights key RMP elements have become a part of the
approaches for authoring RMPs to help MWs to European public assessment report as a lay
avoid errors or prevent unnecessary health summary with transparency implications and a

56 | September 2019 Medical Writing | Volume 28 Number 3

 Materla – The 360º approach to authoring risk management plans

big impact on the MAH’s market position – sures. The concept of “additional monitoring” since the new template had major changes, this
legally, financially, and in terms of reputation.2 was introduced in 2013 for all new medicines posed an impossible task. However, this could be
approved after 2011 to reiterate the importance waived off for some of the RMP updates after HA
A global reference of reporting suspected adverse drug reactions by agreement. Despite these challenges, collab-
EMA’s RMP has been adapted worldwide and the physicians and patients.3 oration amongst the project teams and constant
deemed a reference for other HAs of Rest of the HA interactions have been vital in dealing with
World (ROW) countries (other than EMA or Two years of GVP 2.0: The impact and the changes and in meeting the submission
FDA) either to develop their own RMP guidance trade-off deadlines for RMP updates.
or to accept EMA’s GVP guidelines. An RMP has It has been a couple of years since the industry So far, most HAs of ROW countries with or
been gaining increased importance for newer experienced a major overhaul to the RMP without their own RMP requirements have been
products especially those approved via regulatory template in parallel with the revised GVP accepting RMP submissions in the older format,
procedures that enable earlier patient access (for guidance, version 2.0 in 2017. The extent of but it is anticipated that they will soon adopt this
example, conditional approval for orphan drugs) revisions was substantial but with a more risk- new RMP format. MAHs hope to implement a
without compromising an efficient preliminary proportionate approach crucial to risk-benefit global risk management approach with minimal
assessment of the product’s safety. Nevertheless, evaluation. With major revision to the definitions variations across countries to ensure efficient
such regulatory procedures often need more of identified and potential risks, MAHs are now monitoring of patient safety.
robust reviews by the HAs and a stringent risk clearer about categorising the risks while
management strategy with additional PV ensuring alignment with the adverse drug Importance of medical
activities or risk-minimisation measures beyond reactions defined in the product label. This led to writer’s role
those considered to be routine. This results in an re-evaluation of risk management strategies and The template expert
increase in global cost of RMP implementation development of more appropriate PV plans for Excelling in the art of RMP authoring is not as
for the MAH. each risk in the RMP. Because of these changes, complex as it may seem, provided a logical and
MAHs required additional efforts and resources scientific approach is followed in applying the
Risk-based approach to submit all their revised RMPs within the guidance in any scenario of an RMP develop-
A single product requires a single RMP regardless regulatory deadline before Q2 2018. Moreover, ment. Until the recent revision, MWs interpreted
of the indications, formulations, or dosage forms, this had a direct impact on the existing periodic the GVP template to be too bureaucratic and a
etc., unless otherwise justified by a scientific benefit-risk evaluation reports (PBRERs) for bit ambiguous especially when the rationale
rationale and agreed with the HA. It is a living most of the marketed products. Nonetheless, the behind the requirements was either unclear or
document that is updated continually through- key focus is now streamlined to the information unexplained. One needs to be aware of the
out the lifecycle of a product in the market but, relevant to risk-benefit assessment. On the other nuances of each RMP module and understand
unlike other safety reports, not necessarily at hand, EMA has significantly eliminated redun- the interdependencies across the modules for
regular intervals. The RMP submission require- dant, non-value added requirements or optimal and chronological data flow between the
ments follow a “risk-based approach”. The first integrated sections into more relevant RMP modules. Stakeholders involved in developing
RMP version starts with the first MAA and modules and removed duplication of information regulatory guidance are aware that these are
triggers for subsequent updates include any across other safety documents; for example, the living documents, dependent on the dynamic
significant changes to the marketing authori- section on post-marketing experience is now regulatory landscape with the advent of wide
sation, significant changes to the benefit-risk limited to exposure data rather than a duplication range of new therapeutics. Hence, MWs should
profile, the completion of important milestones of overall periodic safety update report findings. invest extra time in understanding the GVP
for PV activities or risk-minimisation measures , Additionally, changes to the administrative guidance and template, religiously follow them,
or at the request of a HA when new information sections and annexes have eased the job of an and learn to tackle the flaws on a case-by-case
is available from the literature. MW to a great extent, especially reducing the basis. Over time, MWs gain further knowledge
time required to ensure consistency across mod- and experience on the template requirements
Trends in GVP Module V ules. However, the overall concept of mapping, based on rapporteurs’ comments, Pharmacovig-
Journey over a decade which explains the similarity of specific sections ilance Risk Assessment Committee’s assessment
The RMP guidance has been undergoing between RMP modules with the other CTD reports, and health authority questions received
continuous transformation since its inception in modules and PBRER, remained the same in this at different time points after the CTD submission
2007 and has taken a logical shape over the last revision. (e.g. Day 120, Day 180, etc).
12 years in terms of data flow, consistency, and The challenge for MAHs was not only to meet
transparency in a submission-friendly modular the regulatory deadline for submission of all The collaborator
format. Over time, the focus of an RMP has revised RMPs but also to update their internal As with the development of any other regulatory
transitioned significantly from drug safety to standard operating procedures and working document, it is not the sole responsibility of an
patient safety. The evolution represents a guidance documents for regulatory compliance. MW to develop an RMP. It requires a team of
paradigm shift from “safety” to “benefit-risk Apart from these challenges, MAHs had to authors from various departments, not confined
balance”, and introduced the requirement to handle the administrative requirement of creating to safety, clinical, pre-clinical, epidemiology,
evaluate effectiveness of risk-minimisation mea- a “track change version” for existing RMPs and regulatory, biostatistics, data management,

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The 360º approach to authoring risk management plans – Materla

MW should seek relevant contributions on the

scientific aspects of the product from the team.
Basic concepts Eventually, it is the team’s responsibility to
collaborate and integrate with each other to
develop a high quality RMP with minimal or no
health authority questions at least in terms of
360° Approach
template compliance.
to RMP
authoring
The 360° approach
An MW could adapt a holistic approach for
seamless authoring of high quality RMPs and the
concepts detailed below may provide a basic
guidance on a 360° approach towards RMP
authoring (Figure 1).

Basic concepts
Whilst authoring any document, an MW is
expected to have sufficient knowledge on the
Other documents disease or therapeutic areas pertaining to the
product. Beyond this, extensive knowledge and
understanding of PV domain is an additional
prerequisite for authoring RMPs. Probably this is
Figure 1. The 360° approach to authoring a Risk Management Plan. one of the reasons why RMP MWs are usually
titled as “safety” MWs and not “regulatory” MWs.
The GVP guidance covers all the possible
pharmacokinetics, formulation development, etc. should take the lead in guiding the team on RMP definitions that are required in the context of an
Based on the conventional organisational frame- template requirements. Furthermore, an MW is RMP, and an MW should understand their clear
work in the industry, the contributors are often a key collaborator in communicating with other meaning and differences, if any. An MW should
dedicated to specific products but the MW may regulatory MWs on the submission to ensure also be well aware of the different categories of
not be. An MW is deemed to be the template consistency of key messages in the RMP with PV activities and to which category the proposed
expert and a key driver of RMP development various CTD documents (for example, Modules activities belong to. Beyond the RMP guidance,
process since he or she gains a broader 2.7.4, 2.5). an MW can also refer EMA’s guidance on lay
experience on RMP authoring for multiple Likewise, it is the team who has broader summaries, which can be applied to develop the
products compared to any other RMP con- knowledge of a product’s profile and its regu- RMP lay summary for European public
tributor in the project team. Therefore, an MW latory lifecycle rather than an MW. Therefore, an assessment report.4

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 Materla – The 360º approach to authoring risk management plans

PBRERs
CPD modules Special
Epidemiology safety
CSRs reports reports

PK reports Ethnicity reports Labeling documents

(CDS, SmPC/PI)
IB DSURs, Briefing Population PK
document reports
dCDS

CDP
Pre-clinical
study reports
NCO Figure 2. Flow of safety data during drug development.
Abbreviations: CDP, clinical development plan; CDS, core data sheet; CSR, clinical study report; CTD, common technical
document; dCDS, developmental core data sheet; DSUR, development safety update report; IB, Investigator’s brochure; NCO,
non-clinical overview; PBRER, periodic benefit-risk evaluation report; PI, prescribing information; PK, pharmacokinetics; SmPC,
summary of product characteristics.

The template should be aware of the interdependencies Programme history

The framework of an RMP template essentially between the modules and ensure consistency As a single RMP exists for a single product,
follows a typical risk management cycle with across them and also with other documents understanding the overall plan for the clinical
three key elements:1 within the CTD or other safety reports within development programme and leveraging prior
1. What is known and unknown about the safety the regulatory procedure of the submission. submission experience eases the process of RMP
profile of the product? authoring. For example, awareness of the history
2. Which activities are undertaken to collect Product profile of approvals, indications, formulations, triggers
additional data to fill the knowledge gap Since an RMP covers key safety concerns of a for RMP updates, regulatory actions taken for
about the product’s profile? product, an MW should understand its overall safety reasons, Pharmacovigilance Risk Assess-
3. What measures are implemented to mitigate safety profile before beginning to draft an RMP. ment Committee assessment reports, etc. This
the risks? As a starting point, the class of the drug itself knowledge helps an MW to identify specific
provides a clear picture of its pharmacological modules or sections of an RMP impacted and the
Information related to these three elements flow class effects to understand the preliminary safety extent of update required.
chronologically within the modular framework profile of the product. Safety data start to be
of the RMP template. Safety specification module generated from the pre-clinical setting and as the Regulatory context
of the RMP covers all the aspects required to molecule progresses in its lifecycle through the The extent of an RMP update highly depends on
define, categorise, and justify the safety concerns clinical development, more in-depth and reliable the trigger for the update and the regulatory
of a product; which includes epidemiology, pre- safety data become available for adequate safety procedure it falls under (for example, Type I,
clinical and clinical data covering relevant safety, assessment. So, the first comprehensive document Type II variations, renewals, article referrals
efficacy, and pharmacokinetics, limitations of the to refer to would be an investigator’s brochure etc.).5 So, awareness on the context of these
clinical programme, and post marketing data, followed by the developmental core data sheet regulatory procedures helps in understanding the
where applicable. This comprehensive assessment (dCDS) or the current approved label, if scope of an RMP update. Further, it is necessary
is paramount to be able to strategise the applicable. Understanding the chronological flow to understand the context of disease or
remaining elements of an RMP, i.e., PV plan and of safety data from one document to another and therapeutic area of an RMP submission (e.g.
risk-minimisation measures while justifying the realising the differences in purpose behind each paediatric indications, advanced therapy medic-
proposed strategy. Where necessary, MAH may document within the clinical programme helps inal products, biosimilars, generics, associated
need to develop additional PV activities or risk- the MW to refer the right document for precise medical devices). The template requirements
minimisation measures. Therefore, the MW information needed for the RMP (Figure 2). depend primarily on the scope of the submission

www.emwa.org Volume 28 Number 3 | Medical Writing September 2019 | 59

The 360º approach to authoring risk management plans – Materla

and not all sections of the RMP might be consistency with the source documents and depending on the regulatory procedure. The
applicable. Understanding the trigger helps in other documents in the overall programme. This GVP guidance provides a mapping between the
identifying sections or modules impacted during does not mean we have a compelling reason to RMP and CTD modules and with the PBRER as
an RMP update (for example, reaching PV or literally ensure verbatim alignment but only a recommendation. Table 1 and Table 2
risk-minimisation milestones, demotion or ensure message-led alignment. The major docu-
upgradation of a risk etc.). Fundamentally, the ments within the clinical programme that could The programme team
knowledge of current regulatory landscape helps be referred as a source include CTD modules RMP authoring is beyond collating content; it is
in evaluating the impact on RMP updates. (2.7), investigator’s brochure, safety reports, a strategy in itself that is legally binding. There-
labelling documents (CDS or summary of fore, collaborating with the right stakeholders at
Relevance of other documents product characteristics), clinical study report, the right time apart from regular project meetings
The modular format has an obligation to ensure PBRER, development safety update report etc., is imperative in implementing the risk-manage-

Table 1. Mapping between RMP and eCTD modules

RMP Module eCTD

Part I Product(s) Overview Module 2.3 Quality overall summary
Module 3 Quality
Module SI Epidemiology of the indication(s) and target population(s) Module 2.5 Clinical overview
Module SII Non-clinical part of the safety specification Module 2.4 Non-clinical overview
Module 2.6 Non-clinical written and tabulated summaries
Module 4 Non-clinical study reports
Module SIII Clinical trial exposure Module 2.7 Clinical summary
Module 5 Clinical study reports
Module IV Populations not studied in clinical trials Module 2.5 Clinical overview
Module SV Post-authorisation experience Module 2.5 Clinical overview
Module SVI Additional EU requirements for the safety specification Data not presented elsewhere in eCTD
Module SVII Identified and potential risks Module 2.5 Clinical overview (including benefit-risk conclusion)
Module 2.7 Clinical summary (SmPC)
Module SVIII Summary of safety concerns Module 2.5 Clinical overview
Module 2.7 Clinical summary
Part III Pharmacovigilance plan (including post-authorisation safety studies) Module 2.5 Clinical overview
Module 2.7 Clinical summary
Part IV Plans for post-authorisation efficacy studies Module 2.5 Clinical overview
Module 2.7 Clinical summary
Part V Risk-minimisation measures (including evaluation of the effectiveness Module 2.5 Clinical overview
of risk-minimisation activities) Module 2.7 Clinical summary
Abbreviations: eCTD, electronic common technical document; RMP, risk management plan; SmPC, summary of product characteristics.
Source: Guideline on Good Pharmacovigilance practices (GVP), Module V –Risk management system, Revision 2, European Medicines Agency. March 28, 2017.

Table 2. Mapping between RMP and PSUR sections

RMP section PSUR section

Part II Module SIII Clinical trial exposure Sub-section 5.1 Cumulative subject exposure in clinical trials
Part II Module SV Post-authorisation experience Sub-section 5.2 Cumulative and interval patient exposure from marketing experience
Module SVII Identified and potential risks and Module SVIII Sub-sections 16.1 Summaries of safety concerns and 16.2 Characterisation of risks
Summary of the safety concerns
Part V Risk-minimisation measures (including evaluation Sub-section 16. 5 Effectiveness of risk-minimisation (if applicable)
of the effectiveness of risk-minimisation activities)

Abbreviations: PSUR, periodic safety update report; RMP, risk management plan.
Source: Guideline on Good Pharmacovigilance practices (GVP), Module V –Risk management system, Revision 2, European Medicines Agency. March 28, 2017.

60 | September 2019 Medical Writing | Volume 28 Number 3

 Materla – The 360º approach to authoring risk management plans

RMP authoring is
beyond collating
content; it is
a strategy in itself that
is legally binding.

ment strategy. For example, consider the follow- authoring within the constant, dynamic X – Additional monitoring, c2013 [cited
ing opportunities to keep the RMP development regulatory landscape of the GVP legislation. An 2013 Apr 19] Available from:
process moving forward smoothly: MW acts as a “cog in the wheel” throughout the https://www.ema.europa.eu/en/documents
l Collaborate with statistician and statistical RMP development process and has been gaining /scientific-guideline/guideline-good-
programmer during the planning phase to increased importance not only as an active pharmacovigilance-practices-module-x-
review the requirements for mock statistical contributor but also as an expert and a additional-monitoring_en.pdf.
outputs for each safety concern. collaborator in developing high quality RMPs. 4. ec.europa.eu [Internet]. European
l Communicate regularly with the safety lead Commission, Summaries of clinical trial
to get an update regarding any changes to the Acknowledgements results for laypersons , c2017 [cited 2017
safety profile since he/she is the official The author would like to thank Gogula K for Jan 26] Available from: https://ec.europa.eu/
responsible author of an RMP and answer- review feedback. health/sites/health/files/files/eudralex/vol-
able to the qualified person for pharma- 10/2017_01_26_summaries_of_ct_results
covigilance. Disclaimers _for_laypersons.pdf.
l Collaborate with the regulatory affairs rep- The opinions expressed in this article are the 5. ema.europa.eu [Internet]. European
resentative during the planning phase and author’s own and not necessarily shared by her Medicines Agency, Practical questions and
after HA meetings or labelling review com- employer or EMWA. answers to support the implementation of
mittee meetings to be sure you are aware of the variations guidelines in the centralised
any changes to the scope of submission Conflicts of interest procedure. c2016 [cited 2016 Jun 01].
requirements. The author declares no conflicts of interest. Available from: https://www.ema.europa.
l Gather relevant inputs/contributions from eu/en/documents/regulatory-procedural-
the epidemiologist and pre-clinical expert References guideline/practical-questions-answers-
before data availability. 1. ema.europa.eu [Internet]. European support-implementation-variations-
Medicines Agency, Risk-management plans, guidelines-centralised-procedure_en-0.pdf.
Similarly, the MW should provide review c2017 [cited 2017 Mar 28] Available from:
comments to the statistician and the programmer https://www.ema.europa.eu/en/human-
on the mock statistical outputs and identify any regulatory/marketing-authorisation/ Author information
data discrepancies in draft statistical outputs to pharmacovigilance/risk-management/risk- Sushma Materla, MS, has been a medical
avoid major rework and potential delays in the management-plans. writer since 2009 and primarily experienced
submission timelines. Collating clinical inputs 2. ema.europa.eu [Internet]. European in writing clinical summaries and safety
including administrative information on the PV Medicines Agency, Questions and answers documents within Oncology and Diabetes
milestones for clinical studies and the risk-benefit on the risk management plan (RMP) disease areas. She is experienced in
information before and during the content draft summary, c2017 [cited 2017 Mar 30] leadership roles as a lead for RMPs and
stage helps in avoiding last-minute follow-ups. Available from: https://www.ema.europa. patient narratives, programme medical
Throughout the RMP development stages, an eu/en/documents/other/questions- writer, and dedicated submission writer.
MW should ensure that inputs received from answers-risk-management-plan-rmp- She has been training and mentoring the
each contributor are compliant with the template summary_en.pdf. team and contributing for functional
requirements. 3. ema.europa.eu [Internet]. European initiatives to strengthen document
In conclusion, implementing a comprehen- Medicines Agency, Guideline on good excellence within the team.
sive approach eases the overall process of RMP pharmacovigilance practices (GVP) Module

www.emwa.org Volume 28 Number 3 | Medical Writing September 2019 | 61

Trends in regulatory writing:
A brief overview for aspiring medical
writers
Surayya Taranum, PhD
4Clinics, Paris, France

Correspondence to:
Surayya Taranum, PhD
4Clinics
18 rue Goubet
75017 Paris
+33 648214454
[email protected]

Abstract
The EU regulatory system is undergoing a
major overhaul. Several new pieces of
legislation are now in place to enforce
harmonisation and transparency in clinical
trials while ensuring data security and
individual privacy. New and aspiring medical
writers need to be aware of trends in the
regulatory landscape to adapt to new
requirements in technical documentation.
This article is an overview of the evolving
trends in EU regulations for medical devices
(Medical Device Regulation and In-Vitro
Device Regulation) and data compliance
(General Data Protection Regulation and
EMA Policy 0070), and the impact of
artificial intelligence (AI) on the global
medical writing market.
regulatory system for clinical trials and medical million different types of medical devices made
devices in the last few years to create a centralised by more than 27,000 companies.2 The Active
Background and transparent procedure of assessment that can Implantable Medical Devices Directive
The European market comprises of 28 member be implemented across member states. Bio- (AIMDD) 90/385/EEC,3 the Medical Devices
states of the European Union (including the pharma and medical device companies are Directive (MDD) 93/42/EEC4 were introduced
UK), the European Economic Area (Iceland, required to submit documents for approval of in 1992, and the In-Vitro Diagnostics Directive
Liechtenstein, and Norway), Switzerland, and both new and existing products that are in line (IVDD) 98/79/EC5 was introduced in 1998 to
Turkey. As free movement of goods is a key with regulations. The following sections discuss ensure harmonised standards to compliance.
strength of the European Single Market, there are key regulations and trends that are of interest to These directives defined the “essential require-
critical regulations (as listed in the 2016 version medical writers. ments”, which are standards met by the
of the Blue Guide on EU products) in place to manufacturer for the design and production of
ensure safety and quality of products.1 Pharma- New EU medical device the device, its risk assessment and product
ceutical and medical device regulations are regulations marketing to get the Conformite Européenne (CE)
important to ensure safety and efficacy of The European medical devices market is the marking on the device. The MDDs defined three
medicines, and protect public health. The EU has second largest in the world after the US, worth categories of devices based on risk assessment:
witnessed considerable overhaul of the around $115 billion in 2017, with nearly half a l Low-risk Class I devices for which the

62 | September 2019 Medical Writing | Volume 28 Number 3

 Taranum – Trends in regulatory writing: A brief overview

The EU has witnessed considerable overhaul of the

regulatory system for clinical trials and medical devices in
the last few years, in order to create a centralised and
transparent procedure of assessment that is valid
throughout the EU.

Under the MDD, once a medical device The MDR provides a 3-year transition period to
receives its CE mark in one country, the May 26, 2020, and the IVDR a 5-year transition
manufacturer is free to market it to other period to May 26, 2022. By these dates,
countries within the EU. Thus, the MDDs certification of all new devices and recertification
supported the creation of a single market for of existing devices must comply with these
medical devices in Europe. However, their regulations. The regulations will take effect in
interpretation and implementation was left to the every EU member state, and will not require any
2017 2018 2019 2020

discretion of national governments. national legislation for implementation.

In 2010, a global scandal erupted over breast
implants, when it was discovered that the French Impact of the EU MDR and IVDR
company Poly Implant Prothèse was using silicone The MDR incorporates features from the
to fill rupture-prone implant units.6 In 2012, the MEDDEVs that will oversee a shift from a pre-
US FDA published a report on medical devices approval method toward CE marking, to a
approved in Europe but not in the US due to product life-cycle approach to improve
safety concerns.7 Several other adverse events robustness, transparency, and traceability of the
linked to medical devices were reported between regulatory system. The regulation emphasises on
2015 and 2018 that exposed the need for a responsibility for all actors in a product’s life-
regulatory overhaul in the EU. cycle to establish high levels of product safety and
performance. The regulatory transition will affect
Medical Device Regulation and In-Vitro all stages of device development including
Device Regulation production, distribution, and monitoring. Major
New medical device regulations were introduced changes include:
in May 2017 (to replace the MDDs)8,9 to
overcome weaknesses that allow medical devices Reclassification of some medical devices
to stay on the market without sufficient clinical There are additional classification rules to
manufacturer is allowed to affix evidence of their safety and performance, and consider when classifying a medical device, and
the CE mark and register it with to ensure greater harmonisation in imple- some revisions to the existing rules. The term
the national authority, which will mentation across EU member countries. “medical device” is now expanded to include
check if the manufacturer has complied First, the European MEDDEV 2.7.1 products meant for disease diagnosis, implanted
with all the requirements. Rev. 4 guidance on clinical evaluation cosmetic devices, and products that do not have
l High-risk Class II and III devices controlled reports (CER) was published in June a direct medical intent (e.g., sterilisation
through conformity assessment and market 2016 and was a critical component in products, condoms, fillers). The changes in
surveillance procedures by a Notified Body submissions for product approvals. Next, to classification of medical devices may mean that
(NB, which is an accredited organisation that establish a more robust EU legislative framework many devices will be placed in a higher-risk class
conducts conformity assessment of a medical to ensure patient health and safety, the European and subject to additional regulatory require-
device and issues the CE mark) and Parliament approved two key regulations on May ments. Another major amendment is the
Competent Authority (CA, which is a the 25, 2017: recognition of software that is used to diagnose
government body in a member state l Medical Devices Regulation (MDR or treat disease (both standalone and embedded
responsible for transposing the MDD into 2017/745)10 in a device) as a medical device, and subject to
national law, and for specifying the NBs in l In-vitro Device Regulation (IVDR conformity assessment based on its
that member state). 2017/746)11 developmental cycle, risk management, and

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Trends in regulatory writing: A brief overview – Taranum

validation. Devices that are introduced to or evaluation reports (CERs) and CE certifications marketing safety and surveillance activities,
absorbed by the body are placed in a separate were based on product equivalency. The new PSURs, safety and clinical performance reports
classification system. The key changes brought MDR requires technical documents relevant to (SSCP), device registrations, NBs, certificates,
about in the IVDR include genetic testing, each stage of the product cycle. In addition, the serious incidents, clinical investigation data, and
performance evaluation, reference laboratory MDR requires all existing “legacy” medical UDI Information.
testing and a new risk classification system for devices to undergo conformity assessment Ultimately, the MDR aims to bring post-
in-vitro devices (IVDs), and NB involvement in according to the level of risk, even if previously market surveillance of devices into a continuous
majority of IVD certifications. approved under the MDD/AIMDD i.e., no product evaluation and improvement cycle that
“grandfathering” of devices will be considered. is linked to risk management information on the
Role of economic operators Stronger clinical data, including post-market EUDAMED platform.
The new regulation provides guidelines on the safety and performance data are required for the
responsibilities of all economic operators certification and recertification of medical and The challenges ahead
(including manufacturers, distributors, suppliers, in-vitro devices. There will be tighter The MDR requires adherence to stricter
subcontractors, assemblers, and authorised regulations for compliance based purely on regulations to ensure quality and safety of
representatives) in the supply chain for equivalence, requiring in-depth assess- medical devices; it also requires all medical
a medical device with regard to its ments and increased expectations devices to conform to the regulation by May 26,
Whether
technical documentation, labell- of NBs, and rigorous technical 2020. While companies will have until May 26,
ing, complaint submissions, and AI can be documentation methods. 2022 before the IVDR takes effect, ensuring
post-marketing surveillance. sophisticated compliance under this regulation will be a bigger
enough to replace the Post-marketing safety and challenge; under the IVDR, nearly 85% of IVDs
Changes to notified bodies surveillance (an estimated 35,000 IVDs) will require clinical
medical writers
NBs will be subjected to Unlike pharmaceutical drugs, evidence for regulatory approval, compared to
greater scrutiny by CAs; strict remains to be the control point of medical 7% under the IVDD.
designation requirements and seen. devices is through post-marketing The MDR/IVDR also requires all NBs
evaluation of NBs to monitor and surveillance rather than pre-marketing functioning under the MDDs to apply for their
assess their capabilities may mean that a tests. The EU, under the MDDs, relied on NB designation, which must be approved before
number of NBs may not be re-notified. a decentralised approach where national the NBs can proceed with conformity assessment
Designated NBs will work closely with the regulators were responsible for collecting procedures for devices. Due to stringent
European Commission to ensure that their incident reports, and devices were reassessed if requirements for NB designation, the number of
clinical evaluation and post-market clinical follow- safety issues were raised. Under the MDR, it is NBs could be much lower than before; the EC
up plans are adequate before gaining certificates no longer sufficient for manufacturers to review estimates designating 20 NBs by the end of
for certain classes of devices, and will be required and analyse complaints registered on their 2019.12 Brexit adds another layer of complexity
to follow stricter procedures in conformity databases. Companies are required to be as the UK NBs certify a substantial number of
assessments of high-risk Class III medical devices. proactive in gathering information about their medical devices for the EU market; the EC states
devices. Technical documentation under the that in case of no-deal Brexit, all devices certified
Unique Device Identifiers (UDIs) and MDR now requires a post-market surveillance by UK NBs must comply with the EU import
implant cards (PMS), post-market clinical follow-up plan requirements.13 Further, as of July 2019, the EC
Manufacturers are required to include UDI (PMCF) and periodic safety update reports has designated only two NBs for the MDR (BSI
trackers along with the technical documentation (PSUR) that address two main concerns: UK and TÜV SÜD)14 and none for the IVDR,
for the device. The UDI is the key identifier of a l Is the device safe and does it perform its which will increase the NB workload and add to
medical device in the manufacturer’s database intended function? the challenges that manufacturers will face in
and distribution chain, in the European Database l How can the device be improved? ensuring compliance.
on Medical Devices (EUDAMED), on cert- Medical devices typically have short life-
ificates, and on the Declaration of Conformity. The EUDAMED database cycles (2–5 years), fast development timelines,
The UDI will be used in reporting serious EUDAMED stores regulatory information from and tough market competition. The rigorous
incidents and safety correction actions, and in manufacturers and NBs and serves as an requirements for certification under the
identifying counterfeit devices. Implant cards are information exchange platform (a registry for MDR/IVDR, and the increased demand for
required to carry information on the device manufacturers, medical devices, adverse clinical and safety data for medical devices are
lifetime and follow-up procedures for all incidents, authorized representatives, and likely to delay their CE marking, and increase
implantable devices. Declarations of Conformity) between the barriers to entry in the European market.
European Commission and Competent Companies may have to review their portfolios
Clinical evidence Authorities of the member states. Under the to assess whether there will be sufficient return
Under the EU’s MDD 93/42/EEC, clinical MDR, it will also store information on post- on investment for certain products to remain

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 Taranum – Trends in regulatory writing: A brief overview

viable. Upgrading and implementing a quality requirement for marketplace entry” while GDPR, personal data are:
management system to encompass the entire life- balancing pre-market and post-market data …any information relating to an identified or
cycle of a device can also require significant collection to make the system easier to identifiable natural person (“data subject”); an
financial investment, which will have an impact navigate.15 Meanwhile, Latin American countries identifiable natural person is one who can be
on small and mid-sized companies. As a result, with faster marketing approval processes are also identified, directly or indirectly, in particular by
some estimates indicate that the number of emerging as an attractive option for medical reference to an identifier such as a name, an
certified devices entering the EU market could device companies.17 identification number, location data, an online
reduce by 30%, and that up to 50% of devices The months leading to May 27, 2020, when identifier or to one or more factors specific to the
could die out.15 the MDR takes effect will present a lot of physical, physiological, genetic, mental, economic,
Traditionally, the EU was the first market to uncertainty and challenges for medical techn- cultural, or social identity of that natural person.
receive new medical technology, as the MDDs ology companies. At the same time, the increase
provided quicker channels to implementation for in documentation required for medical device The GDPR applies to any organisation that
new medical devices than the FDA. One approval means that more medical writing handles data that comes from EU citizens,
consequence of the MDR/IVDR would be that opportunities will become available. Medical including companies based in the EU and those
companies seek to develop and launch their writers will be able participate in developing that collect (controllers) or process
products outside Europe at first, and enter the technical documentation for entire product life- (processors) data from EU citizens. It is a
European market once they have gathered cycles, and gain deeper insights into the fast- complex regulation that identifies data as
sufficient clinical and post-market surveillance developing, innovative medical technology anything that can identify an individual directly
data. Companies that relied on EU certification industry. or indirectly; non-compliance can result in
to market their products in other countries (e.g., significant financial penalties. The scope of
Australia and the US) may re-evaluate their sales GDPR vs. EMA Policy 0070 – GDPR in healthcare broadly encompasses these
strategies and opt to obtain market clearance A balancing act key takeaways:
outside the EU.16 The US FDA has announced The EU General Data Protection Regulation l Strict definition of patient consent while
its strategic priorities during the 3-year MDR (GDPR)18 is a set of compliance regulations that acquiring personal data − organisations are
transition period to take steps to “reduce the time came in effect on May 25, 2018, to harmonise expected to obtain explicit consent for the
and cost of generating clinical evidence, typically data protection and privacy of all EU citizens collection and storage of all personal data, and
the most expensive and lengthy regulatory across all member states. According to the to be transparent about its intended use.

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Trends in regulatory writing: A brief overview – Taranum

The EU Clinical Trial Regulation 546/2014 (which replaced the EU Clinical Trial Directive No. 2001/20/EC)
aims to harmonise clinical trial submission and assessment across EU member states, and ensure highest standard
of safety for trial participants and transparency of information sharing.

l Removal of patient data or the patient’s right for trial participants, and transparency of ation of participants is essential to ensure privacy
to be forgotten – organisations can no longer information sharing.19 EMA Policy 0070 and prevent re-identification of patients in trial
hold personal data indefinitely and are (released in March 2016) enables access to documents that are disclosed to the public. To
required to delete all information perman- clinical trial documents by academics and ensure highest standard of data protection,
ently upon a patient’s request. researchers to enrich scientific expertise and clinical trial documents under EMA 0070 policy
l Data protection – all organisations that collect innovation within the pharmaceutical industry.20 will be disclosed in two phases:
and store patient data must take measures to Under EMA Policy 0070, companies are l Phase I concerns disclosure of common
ensure security, pseudonymisation, and data required to make GDPR-compliant public technical document (CTD) clinical overview
privacy to avoid compromising patient data. disclosure of selected clinical trial documents in (Module 2.5), clinical summaries (Module
Risk assessment procedures must be in place a public portal. The policy is applicable to trials 2.7), Clinical Study Reports (CSR) and its
to address any data breaches. conducted within and outside the EU; including appendices (including the protocol and its
approved, disapproved, and withdrawn market- amendments, case report forms, and
The EU Clinical Trial Regulation 546/2014 ing authorisation applications. statistical analysis plans).
(which replaced the EU Clinical Trial Directive The two legislations make it imperative for l Phase II will include the publication of
No. 2001/20/EC) aims to harmonise clinical organizations to find the right way to balance data anonymised individual patient data, and will
trial submission and assessment across EU protection and privacy requirements with be implemented after Phase I disclosures are
member states, ensure highest standard of safety transparency and public disclosure. Anonymis- complete.

66 | September 2019 Medical Writing | Volume 28 Number 3

 Taranum – Trends in regulatory writing: A brief overview

This requires the practice of rigorous methodol- patient-focused treatments while reducing and AI-enabled approaches where the PV system
ogy and anonymisation techniques in preparing healthcare costs. can interpret and analyse the source documents,
trial documents. Proactive anonymisation can be The second annual RWE Benchmarking perform seriousness assessment and medical
used by removing (e.g., patient name and Survey from Deloitte reports that 90% of review on appropriate content.
geographic location) or replacing sensitive pharmaceutical companies are building RWE
information (e.g., banding, where age is replaced analytic capabilities through the entire product Can AI-enabled technology replace medical
by age range, or calendar dates by relative dates) cycle via investments, technology, and external writers?
to avoid redaction during public disclosure of collaborations.25 RWE is useful both in Given the range of AI-enabled functions, there is
documents. To ensure transparency during improving clinical trial design and execution now an increasing interest in its applications in
redaction, an anonymisation report that includes through upstream incorporation of RWE-driven regulatory documentation. The ultimate concern
the methods of redaction and their impact on expertise (e.g., use of synthetic control arm for medical writers is whether AI and machine
data quality is required.21,22 A risk assessment instead of an actual control arm), as well as learning can replace their role in preparing
plan is also critical for mapping out the monitoring post-launch safety of drugs. technical documents.
procedures to follow in case of a re-identification The process of collecting and using RWE is Following the EMA 0070 policy, there is
attack. not straightforward, and there is a dearth of interest in using AI applications in redacting
In addition to ensuring compliance in clinical standardised and reliable procedures that can be sensitive information from clinical trial
trial documents, it is essential that information integrated in clinical studies. Typical sources of documents. While AI-enabled automation so far
on all other platforms (e.g., journal publications, RWD include insurance claims, electronic health has not made major inroads into regulatory
company websites, regulatory agency websites, records (EHR), patient registries, patient- writing, technologies that enable automation of
congress abstracts and posters, patient organi- generated data (e.g., mobile and wearables, or at least part of the regulatory document
sation websites) is consistent with clinical trial “Internet of Things” devices), patient-reported preparation are already available. For example,
data on public databases. Medical writers have a outcomes, and social media insights. How useful Synchrogenix has developed an innovative
critical role in ensuring a balance between public data can be extracted from these diverse channels platform combining SaaS-based AI and natural-
disclosure of trial documents without com- and analysed for clinical investigations in a language processing technology that uses
promising GDPR compliance, maintaining GDPR-compliant manner remains a challenge.26 context-based understanding in automated
transparency, and gaining public trust. Automation of data extraction, retention and authoring tasks.30 The Synchrogenix AI tool is
expiry can help ease the burden of regulatory capable of taking information from previous
Artificial intelligence and compliance while enabling companies to capture study documents including CTDs, statistical
medical writing and evaluate valuable RWD. analysis plans, tables, and figures, and placing
The fast-evolving artificial intelligence (AI) them under the right sections of a CSR. Recent
technology has the potential to disrupt every Data mining in pharmacovigilance reports about the first AI-generated textbook
stage of the $63 billion clinical trials market, from The WHO defines pharmacovigilance (PV) as using machine learning,31 automation of
drug design, patient recruitment and medication “the science and activities relating to the scientific writing and literature research through
adherence, to gathering real-world evidence.23,24 detection, assessment, understanding, and neural networks32,33 carry the promise of
Some of the challenges that AI-enabled prevention of adverse effects or any other drug- speeding up scientific and technical document
technology can be used to address include: related problem”.27 With the advent of digital preparation, and are likely to be widely used by
media, the number of adverse events (AEs) medical writers in the future.
The challenge of real-world evidence reported has increased dramatically; in 2017, the The sweeping regulatory changes in recent
Traditional clinical trials are the gold standard for FDA received reports of over 1.8 million AEs years are proving to be a rich opportunity for
evaluating a drug’s risk/benefit profile, but are related to drug use, a 400% increase from the growth in medical writing. In fact, according to a
not comprehensive enough to explain how the 363,171 reports it received in 2007.28 To build report by Acumen Research and Consulting,
drug will perform in the ‘real world’ with a robust drug safety surveillance systems, pharma from 2019−2026, the global medical writing
heterogeneous patient population. Real-world companies are seeking to mine “big data” to market is expected to grow to US$3.6 billion.34
evidence (RWE) is information derived from real identify AEs from other electronic data sources, For PhDs seeking to transition outside academia,
world data (RWD), or health data acquired including EHRs, medical literature, and social there has never been a more exciting time to be a
outside of a clinical trial i.e., during clinical media.29 The sheer volume of available data raises medical writer!35
practice. The need for RWD exists because the cost of collecting, evaluating, processing, and
conventional approaches to drug development reporting of AEs. Companies are increasingly Conflicts of interest
are time and cost-intensive (exceeding 8 years in turning to PV automation to streamline process The author declares no conflicts of interest.
development with costs of over $2 billion), and steps, reduce time and labour costs, and speed
come with no guarantee for success. Therefore, it information delivery while ensuring compliance.
is important to analyse and integrate RWE in Examples include robotic automation of manual
healthcare to empower physicians, and provide steps that do not require human intervention,

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Trends in regulatory writing: A brief overview – Taranum

References rapid/press-release_ MEMO-17- innovation-while-us-fda-eases-

1. European Commission. The ‘Blue Guide’ 848_en.htm. regulations/.
on the implementation of EU products 9. European Commission. Regulatory 16. Parenteral Drug Association. European
rules. 2016 [cited 2019 Aug 05]. Available framework. [cited 2019 August 05]. Implementation of Medical Device and
from: https://eur-lex.europa.eu/legal- Available from: https://ec.europa.eu/ IVD Regulations - Implications for
content/EN/TXT/PDF/?uri=CELEX:52 growth/sectors/medical-devices/ Australia. 2019 [cited 2019 August 05].
016XC0726(02)&from=BG. regulatoryframework_en#new_regulations. Available from:
2. MedTech Europe. The European Medical 10. Eur-Lex. Regulation (EU) 2017/745 of the https://pda.inloop.com/en/
Technology Industry 2019. [cited 2019 European Parliament and of the Council of article/123034?id=123034.
August 05. Available from: 5 April 2017 on medical devices. 2017 17. Martinez-Clark JG. Latin America Offers
https://www.medtecheurope.org/wp- [cited 2019 August 05]. Available from: Welcoming Entry Market Amid Tighter EU
content/uploads/2019/04/The-European- https://eur-lex.europa.eu/eli/ Regulations. 2019 [cited 2019 August 05].
Medical-Technology-Industry-in-figures- reg/2017/745/oj. Available from:
2019-1.pdf. 11. Eur-Lex. Regulation (EU) 2017/746 of the https://www.meddeviceonline.com/doc/
3. EUR-Lex. Council Directive 90/385/EEC European Parliament and the Council of 5 latin-america-offers-welcoming-entry-
of 20 June 1990 on the approximation of April 2017 on in vitro diagnostic medical market-amid-tighter-eu-regulations-0001.
the laws of the Member States relating to devices. 2017 [2019 August 05]. Available 18. GDPR.EU. Complete guide to GDPR
active implantable medical devices. 1990 from: https://eur-lex.europa.eu/legal- compliance. [cited 2019 August 05].
[cited2019 August 05]. Available from: content/EN/TXT/PDF/?uri=CELEX:32 Available from: https://gdpr.eu/.
https://eur-lex.europa.eu/legal- 017R0746&from=EN. 19. Thomas KB. Clinical trial disclosure and
content/EN/TXT/?uri=CELEX%3 12. Emergo. State of flux: European Notified transparency: Regulation EU No.
A31990L0385. Body numbers decrease further ahead of 536/2014, Public disclosure at the clinical
4. EUR-Lex. Council Directive 93/42/EEC MDR, IVDR. 2019 [cited 2019 August trial level. Med Writ. 2018;27(2):7–17.
of 14 June 1993 concerning medical 05]. Available from: 20. European Medicines Agency. European
devices. 1993 [cited 2019 August 05]. https://www.emergobyul.com/blog/2019 Medicines Agency policy on publication
Available from: https://eur- /07/state-flux-european-notified-body- of clinical data for medicinal products for
lex.europa.eu/LexUriServ/LexUriServ.do? numbers-decrease-further-ahead-mdr-ivdr. human use (EMA Policy 0700). 2019
uri=CONSLEG:1993L0042:20071011: 13. Mondaq.com. European Union: Update [cited 2019 August 05]. Available from:
EN:PDF. On The Implementation Of The European https://www.ema.europa.eu/en/document
5. EUR-Lex. Directive 98/79/EC of the Medical Devices Regulation And In Vitro s/other/european-medicines-agency-
European Parliament and of the Council of Diagnostics Regulation. 2019 [cited 2019 policy-publication-clinical-data-medicinal-
27 October 1998 on in vitro diagnostic August 05]. Available from: products-human-use_en.pdf.
medical devices. 1998 [cited 2019 August http://www.mondaq.com/unitedstates/x/ 21. Billiones R. Anonymisation reports from
05]. Available from: https://eur-lex. 832142/Healthcare/Update+On+The+Im 2016 to 2017: A preliminary analysis. Med
europa.eu/eli/dir/1998/79/2012-01-11. plementation+Of+The+European+Medica Writ. 2018;27(2):22–6.
6. Frumento C. French breast implants, the l+Devices+Regulation+And+In+Vitro+Di 22. Martinsson L. Preparing anonymisation
Medical Device Regulation, and a agnostics+Regulation. reports in general and for an orphan drug in
theoretical case study. Med Writ. 14. RAPS. EU MDR/IVDR: US Raises particular. Med Writ. 2018;27(2):27–30.
2017;26(2):39–40. ‘Serious Concerns,’ Urges 3-Year 23. CB Insights. The clinical trials industry
7. US Food and Drug Administration. Unsafe Implementation Delay. 2019 [cited 2019 needs a makeover. Here are the
and ineffective devices approved in the EU August 05]. Available from: technologies looking to shake up the
that were not approved in the US. Silver https://www.raps.org/news-and- $65B market. 2019 [cited 2019 August 05].
Spring, MD: US Food and Drug articles/news-articles/2019/8/eu- Available from:
Administration; 2012 [cited 2019 August mdrivdr-us-raises-serious-concerns-urges-3 https://www.cbinsights.com/research/
05]. Available from: ?utm_source=MagnetMail&utm_medium clinical-trials-technologies/.
http://www.elsevierbi.com/~/media/ =Email%20&utm_campaign=RF%20Toda 24. CB Insights. The future of clinical trials:
Supporting%20Documents/The%20Gray y%20%7C%202%20August%202019. how ai & big tech could make drug
%20Sheet/38/20/FDA_ EU_ Devices_ 15. Vascular News. Europe braces for harder development cheaper, faster, & more
Report.pdf. times in medical device innovation while effective. 2018 [cited 2019 August 05].
8. European Commission. Press release – US FDA eases regulations. 2018 [cited Available from:
New EU rules to ensure safety of medical 2019 August 05]. Available from: https://www.cbinsights.com/research/
devices. 2017 [cited 2019 August 05]. https://vascularnews.com/europe-braces- clinical-trials-ai-tech-disruption/
Available from: http://europa.eu/ for-harder-times-in-medical-device- 25. Deloitte. Getting real with real-world

68 | September 2019 Medical Writing | Volume 28 Number 3

 Taranum – Trends in regulatory writing: A brief overview

evidence (RWE). 2018 [2019 August 05]. articles/PMC5969211/. 34. GlobalNewswire. Medical writing market
Available from: http://learn.deloitte.com/ 30. Brennan Z. Synchrogenix acquires size worth around US$ 3.6 billion by 2026.
rwe-survey-deloitte-insights. AI-assisted medical writing company Acumen Research and Consulting 2019
26. Cynober T. Artificial intelligence in ClinGenuity. Outsourcing-pharma 2015 [cited 2019 August 05]. Available from:
oncology: Fantasy or reality? Labiotech.eu [cited 2019 August 05]. Available from: https://www.globenewswire.com/news-
2019 [cited 2019 August 05]. Available https://www.outsourcing- release/2019/06/11/1867022/0/en/Medi
from: https://labiotech.eu/features/ pharma.com/Article/2015/01/07/Synchr cal-Writing-Market-Size-Worth-Around-
artificial-intelligence-oncology/?utm_ ogenix-acquires-AI-assisted-medical- US-3-6-bn-by-2026.html.
source=twitter&utm_medium=social&ut writing-company-ClinGenuity. 35. Alechine E, Basu S, Chang C. Cheeky
m_campaign=meetedgar. 31. Vincent J. The first AI-generated textbook medical writers: Transitioning from
27. World Health Organization. Looking at the shows what robot writers are actually good academia to medical writing. Med. Writ.
pharmacovigilance: ensuring the safe use of at. The Verge 2019 [cited2019 August 05]. 2018; 28(1):20–3.
medicines. [cited 2019 August 05]. Available from: https://www.theverge.
Available from: http://apps.who.int/ com/2019/4/10/18304558/ai-writing-
medicinedocs/pdf/s6164e/s6164e.pdf. academic-research-book-springer-nature-
28. Clark R. 62% of Drug Safety Experts Say artificial-intelligence.
They’re Using AI to Improve Adverse Event 31. Chandler DL. Can science writing be
Reporting. 2018 [cited 2019 August 05]. automated? MIT News 2019 [cited 2019
Available from: https://www.copyright. August 05]. Available from: Author information
om/blog/drug-safety-using-ai-adverse- http://news.mit.edu/2019/can-science- Surayya Taranum, PhD, is a Scientific Writer
event-reporting/. writing-be-automated-ai-0418. at 4Clinics. She is also Director for
29. Ventola CS. Big data and pharma- 33. Extance A. How AI technology can tame Membership at the Healthcare Business-
covigilance: Data mining for adverse drug the scientific literature. Nature 2018 [cited women’s Association (HBA) Paris Chapter,
events and interactions. 2018 [cited 2019 05 August 2019]. Available from: and Communications Lead at the HBA
August 05]. Available from: https://www.nature.com/articles/d41586- Entrepreneurship Group.
https://www.ncbi.nlm.nih.gov/pmc/ 018-06617-5.

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www.emwa.org Volume 28 Number 3 | Medical Writing September 2019 | 69

The medical writing landscape
in China
Clare Chang Introduction profession that has emerged and taken off in
dMed Biopharmaceutical, Shanghai, China Medical writing exists on a broad spectrum China. According to Dr Ning Zheng (2018,
ranging from regulatory medical writing to medical personal interview with N. Zheng; un-
science writing.1 Therein, the corresponding referenced), Medical Writing Associate Director
Correspondence to: drivers of trends in medical writing span from at dMed Biopharmaceuticals (a contract research
Clare Chang regulatory changes to new discoveries and organisation in China), China has been
dMed Biopharmaceutical cultural changes. Extensive reforms in regulations “repeating the history seen in Europe and the US,
298 Xiangke Road, 3F, 301-305, since China joined the International Council for where clinical research physicians (CRPs) also
Zhangjiang, Hi-Tech Park, Pudong, Shanghai Harmonisation of Technical Requirements for prepared documents and medical writing was not
201210, China Pharmaceuticals for Human Use (ICH) as a new a distinct profession”. It was considered strange
(+86)186 168 23601 Regulatory Member have inevitably changed the that you needed someone to help you develop a
[email protected] clinical development landscape countrywide, document and it was also “difficult to persuade
and of course, everything related to document management as to why you needed a special
preparation for the regulatory medical writer.2,3 writer”. Although it is true that CRPs can write,
Abstract Contrastingly, medical science writing – the medical writers may express the idea more
The Chinese medical regulatory writing and dissemination of scientific and medical infor- clearly. Amidst the work that many CRPs have
medical science writing landscapes are chang- mation to the general public – is largely deter- (medical monitoring and communicating with
ing rapidly. Changes in regulatory reforms mined by the language and medium through principal investigators), they may not necessarily
continue as China further strives to align its which communication occurs and these revolve have sharpened and honed their writing skills.
pharmaceutical industry with the world, around culture and trends. This article explores “As medical writers, we write every day, hence we
which necessitates collaborative writers who the recent trends in medical regulatory writing have more experience, but we still need input
are capable of keeping up with both changes and medical science writing, as well as the from physicians because they have the thera-
in regulations and innovative medicine. essential skills to becoming a successful medical peutic expertise”. Indeed, the medical regulatory
Medical science writing is dependent on the writer in China. writing profession has grown in China in recent
adaptation of the material to suit Chinese times as more and more companies see the value
media platforms. Despite the vast differences Medical regulatory writing in outsourcing work to medical writers or even
in regulatory writing and medical science trends in China having an in-house team.
writing, the essential skills are similar – under- Brief history of medical regulatory writing Dr Nan Wang, Head of Global Medical
standing data and knowing one’s audience. Regulatory medical writing is a relatively new Writing at Bayer HealthCare (China/Finland)

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 Chang – The medical writing landscape in China

(2018, personal interview with N. Wang; un- because it calls for the use of Common Technical regulatory environment, while opening doors for
referenced), added that as “regulatory require- Document (CTD) modules for the submission truly innovative new drug development and
ments became tighter and with research and of documents. This year, the NMPA has started opportunities. Being able to comply with the
development on the rise in China” there came a to ask for public comments on electronic CTD ICH guidelines, while keeping up with the fast-
“bidirectional need” for efficient clinical implementation.5 All these guidelines call for changing landscape and retaining document
development: global pharma companies needed more efficient document handling and transf- quality, has become more important than ever.
to start adhering to the more stringent erability in documents across regions worldwide.
regulations, meanwhile local companies wanted A major change in the procedures for Essential skills for the medical regulatory
to go global. As such, “a strong market need for investigational new drug (IND) applications writer
medical writers” has arisen; however, not only /new drug applications (NDA) (Notice No. 50 Ning revealed that the title Medical Writer can be
was there a “limited” supply of writers, everyone 2018) also came in 2018.6 This was followed by “misleading” because writing is a must – you
was also rather “inexperienced”. This is how the procedures on setting up a pre-IND meeting need good grammar and the ability to express
scattered regulatory medical writers of China (Notice No. 74 2018).7 Briefly, the optimised logically; however, other skills include “attention
came together in 2014 and formed a medical IND and NDA approval times are now 60 and to detail” and the ability to “keep calm under
writing community. The group is active on 150 working days, respectively. This allows com- stress” (2018, personal interview with N. Zheng;
WeChat and has become a platform for panies to consider involving the Chinese market unreferenced). More importantly, project man-
knowledge exchange. They also represent early on during pivotal developmental stages. agement plays a bigger part and is the more
Chinese medical writers and help bridge Further, a single IND approval is valid challenging aspect to medical writing. Some
Chinese medical writers with the Being from Phase I through to III. To examples Ning mentioned include how to
world. At the time of writing, the further close the gap, the Centre “manage reviewers especially when they do not
a compelling
community contains an avid for Drug Evaluation released a follow your timeline”, how to “engage your
group of 400-500 members. storyteller and engaging List of Urgently Needed project team” to complete tasks, how to rise
the audience on relevant Overseas Drugs – drugs above “cultural challenges” when working in
Recent regulatory changes platforms to pass on already approved in Japan, international teams, and how to “manage
Rapid changes in Chinese the EU, or the USA – to allow stakeholders who are often of higher seniority
jargon-heavy and difficult
drug regulations call for direct market application for than you”. These all boil down to effective
changes in document develop- concepts easily are said drugs as long as ethnic communication and coordination.
ment for a medical writer. In early critical. insensitivity can be demon- Nan agrees and further explains that medical
2018, the National Medicinal strated.8,9 These changes directly writing is a “cross-discipline job where you need
Products Administration (NMPA) affect the overall timelines for document to communicate effectively with others, while
implemented five secondary ICH guidelines development with which medical writers are controlling, managing, and finding risks to
(Notice No. 10 2018): M4, E2A, E2D, M1 and normally used to in China; the average waiting complete a project” (2018, personal interview
E2B (R3).4 E2A, E2D, and E2B (R3) define time for an IND application was 14 months with N. Wang; unreferenced). Being a fast learner
standards for safety reporting. For medical between 2013-2015.10 to grasp the crux of a project while not being the
writing, the implementation of M4 is a big step Joining the ICH has led to a more stringent subject matter expert is very important. As Nan

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The medical writing landscape in China – Chang

Guokr (a science writing agency in China) (2018, China. You may find booking an appointment at
personal interview with M. Jia; unreferenced), a hospital difficult because the hospital may not
commented that the purpose of science writing necessarily have a website or that the website may
is “to provide the public with general health- be outdated. However, if you search for them
related and medical knowledge”, such as common using WeChat, the hospital may have a WeChat
diseases, remedies, how to overcome certain mini-programme through which you may find
diseases, how to communicate with the doctor, updated information, book an appointment, and
and shed light on doctors’ perspectives. “It is a find relevant reviews on different doctors.
platform for communication”. Articles are varied Not only does success in getting information
and range from general information to cutting- lie in navigating the different methods of social
edge research. Mingyue mentioned that media use but so does success in informing.
many of the articles they worked on A study showed that retweets on
are sourced from overseas; these Weibo (a Chinese social media
can be both journal publications The common platform) were higher than
as well as articles written by essential skill is to retweets on Twitter by several
recalled, “being able to design or contribute to other science writing agencies. deliver the message orders of magnitude; therein,
the design of a protocol may not be that The key to science writing is the pictures, videos, and links
most efficiently to
important for a writer; instead, the ability to fine balance between “accuracy accounted for a large percentage
‘borrow’ another person’s knowledge to com- and attraction”. For Mingyue, very different target of the tweets.13 This is because
plete a project is more important. To me, this was analogies, adapting for cultural readers trends in China are largely set by
a difficult thing to do in the beginning”. She differences, and relevance are key to the public retweeting content while
reasoned that when you write a document, the drawing their readers’ attention; this is the trends on Twitter are often attributed to
document is not the limit. “Frequently, it fun and artistic side of medical journalism. “Just news sources or information from organisations
encompasses an entire therapeutic area and laying out the hard facts and jargon will bore the that people follow. So, if you want to run a
learning is infinite. So, what is actually more reader”. She mentioned that one of the biggest successful campaign in China, you need to
important is the ability to use the right resources differences in science writing between China and consider the difference in practice.
effectively in the limited time to complete a the US is that the US has a longer history and a While most of the world uses social media
project”. more solid foundation. This can be attributed to platforms such as Facebook, Twitter, YouTube, etc.,
the fact that high impact science journals are in China uses its own versions of social media
Science writing in China English making it easier for science writers to platforms as a result of nationwide regulation of
Brief history of science writing “rewrite” the original source into an article that the internet (i.e. The Great Firewall of China).
Science writing (also known as popular science can be understood by a lay audience. In China, The most common are Weixin (or WeChat), Sina
in China) is the dissemination of scientific original materials in English have to be translated Weibo, and Tencent QQ. If we look at the figures,
content to the general public. Science writing and cultural differences, habits, and relevance to quote Gary Liu (CEO of the South China
dates back to the late 1940s and was initiated by have to be considered. These are all key to public Morning Post) from his Ted Talk,14 “By the end
The Ministry of Culture, which stagnated during outreach, which, in modern times, revolve of 2017, the Chinese internet population had
the Cultural Reform between the 1960s and around social media. reached 772 million users. That’s larger than the
1970s.11 After the 1970s, the Chinese govern- populations of the United States, Russia, of
ment encouraged science associations to dis- Platforms for dissemination in China Germany, of the United Kingdom, of France and
seminate scientific findings to the general public In recent times, China has shifted from website- Canada combined. Ninety-eight percent of them
so that they can benefit from it through lifestyle based dissemination to mobile-app based are active on mobile. Ninety-two percent of
changes. With the advent of technology and as dissemination, thereby affecting lifestyle and them use messaging apps. There are now 650
China started to open up, science writing took off habits. Contrastingly, most Western societies are million digital news consumers, 580 million
since information was no longer propagated only used to accessing information via websites. The digital video consumers, and the country’s
by the government and professional associations. conundrum is that many businesses in China do largest e-commerce platform, Taobao, now
Over time, the public’s engagement has risen12 – not own or maintain a website; instead, they boasts 580 million monthly active users. It’s
in the age of information, publishers, science maintain businesses on mobile platforms (such about 80 percent larger than Amazon”. This is a
communication agencies, and even the public as WeChat), and the contents of the mobile huge untapped market for non-Chinese
have joined in. platform are only accessible on the phone and companies! Beside the language barrier, which
Science writing, particularly with regard to not through websites. Imagine a version of can be easily overcome by translators and
medical content (medical science writing), in Facebook or Twitter where the posts you post and interpreters, another challenge lies in navigating
China is much like science writing in other parts read are only available while using the cellphone the Chinese internet, and this is crux to success
of the world. Mingyue Jia, a medical writer at app. Mobile-based platforms are the default in in the Chinese market.

72 | September 2019 Medical Writing | Volume 28 Number 3

 Chang – The medical writing landscape in China

Essential skills for medical science writing Conflicts of interest 9. National Medical Products Administration.
For those interested in medical science writing, The author is employed by dMed Biopharma- NMPA notice on the urgent need for
Mingyue mentioned that “good writing skills” are ceuticals but the views and opinions in this article approved overseas drugs (Notice No. 79,
a must (2018, personal interview with M. Jia; are entirely her own. 2018). 2018. [cited 2019 Apr 5]. Available
unreferenced). Considering that some of the from: http://www.nmpa.gov.cn/
articles are published in English journals, good References WS04/CL2050/331475.html.
English skills are also a prerequisite. Although a 1. McIntosch I. Broad-spectrum medical 10. Wang M. Clinical trials and drug approvals
medical background (for medical-related content) writer: Nature or nurture? TWS. continue to accelerate in China. Lancet
is preferable, those without a medical background 2009;13:7–8. Oncol. 2017;18(7):855.
must be able to grasp the concepts easily and 2. The International Council for 11. Miao R, Zhao J. A comparative study on
possess good reasoning skills. Most of Mingyue’s Harmonisation (ICH). The Association popular science between China and the
colleagues have either a Bachelor’s or Master’s begins new work on medicines for children United States. 2016 International
degree. Since medical science writing targets a and better clinical trials and China Food Symposium on Educational Technology
wider audience, the ability to engage and connect and Drug Administration joins ICH. 2017; (ISET); 2016 Jul 19-21; Beijing, China.
the dots through wordsmithing, storytelling, and Montreal, Canada. ICH Press Release. Beijing: IEEE;2016. Conference paper.
creative metaphors are essential. Finally, depend- 3. Cooper J, Yang R, Wati H, Hirayama R, 12. Zhang JY. The ‘credibility paradox’ in
ing on the purpose, being able to use and navigate Lu B, Kang S, et al. Medical writing for China’s science communication: Views
Chinese social media platforms is a bonus. submission to Asia-Pacific regulatory from scientific practitioners. Public
authorities. Medical Writing: The Underst Sci. 2015;24(8)913–27.
Conclusion Backbone of Clinical Development. 2017: 13. Yu L, Asur S, Huberman BA. What trends
The medical writing landscape is changing May: 1-8. in Chinese social media. The 5th SNA-
rapidly in China. For regulatory writing, being 4. National Medical Products Administration. KDD Workshop; 2011 Aug 21; San Diego,
able to keep up with the rapid changes in local Notice on the application of ICH CA, USA. New York: ACM;2011.
regulations while working with the team to Ssecondary guidelines (Notice No. 10, Conference paper.
develop documents are essential. Luckily, a very 2018). 2018 [cited 2019 Apr 5]. Available 14. Liu G. Gary Liu: The rapid growth of the
active group of Chinese regulatory writers are from: http://www.nmpa.gov.cn/ Chinese internet – and where it’s
there to support each other. For medical science WS04/CL2182/300493.html. headed [Internet]. Location: TED; 2018.
writing, the government has passed the popular- 5. Center For Drug Evaluation. Notice on Video: 12 min. Available from
isation of science ball onto publishers and the public solicitation for comments on https://www.ted.com/talks/gary_liu_the_
public. Being a compelling storyteller and technical specifications on eCTD and rapid_growth_of_the_chinese_internet_
engaging the audience on relevant platforms to eCTD verification standards. 2019. [cited and_where_it_s_headed.
pass on jargon-heavy and difficult concepts easily 2019 Apr 5]. Available from:
are critical. The common essential skill is to http://www.cde.org.cn/news.do?method=
deliver the message most efficiently to very viewInfoCommon&id=314816.
different target readers – health authorities for 6. National Medical Products Administration.
regulatory writing and the public for medical NMPA announcement on the adjustment
science writing – even though the data behind of procedures for investigational new drug
could be the same. application (Notice No. 50, 2018). 2018
[cited 2019 Apr 5]. Available from:
Acknowledgements http://www.nmpa.gov.cn/WS04/CL2111
I would like to thank Ning Zheng, Nan Wang, /329716.html.
and Mingyue Jia for their precious time in 7. National Medical Products Administration.
allowing me to interview them about medical NMPA circular on pre-IND
writing in China for the preparation of this communication and management (Notice Author Information
article. I would also like to thank them all for No. 74, 2018). 2018. [cited 2019 Apr 5]. Clare Chang, PhD, is a molecular biologist.
reading and reviewing the article and providing Available from: http://www.nmpa.gov.cn/ She started freelance translating, writing, and
diligent feedback. Many thanks to Joyce Salita, WS04/CL2050/331245.html. editing in 2008. She is a member of EMWA.
who proof read and edited the article. 8. Center For Drug Evaluation. Second She currently works as an associate manager
announcement for urgent need of approved in medical writing at dMed Biopharma-
Disclaimers overseas drugs. 2019. [cited 2019 Apr 5]. ceutical, China. In her free time, she enjoys
The opinions expressed in this article are the Available from: http://www.cde.org.cn/- moderating and contributing to the Medical
author’s own and not necessarily shared by her news.do?method=viewInfoCommon&id= Writing Organization.
employer or EMWA. 314835.

www.emwa.org Volume 28 Number 3 | Medical Writing September 2019 | 73

News from the EMA SECTION EDITORS

●
✒ Section Editor:
Anuradha Alahari
[email protected]
The articles included in this section are a selection from the European Medicines Agency (EMA)’s
News and Press Releases archive from April 2019 to June 2019. More information can be found on
the Agency’s website: www.ema.europa.eu
●
✒
EMA contact:
Monika Benstetter,
[email protected]

Re-analysis of data on use of breast cancer medicine Tyverb following treatment with trastuzumab

April 30, 2019 – European Medicines Agency previously treated with trastuzumab. that the cancer has started to spread locally
(EMA) is updating the prescribing information In the light of this new information, doctors and ‘metastatic’ means that the cancer has
for Tyverb (lapatinib) following detection of currently treating patients with Tyverb in spread to other parts of the body;
errors in results of a study involving post- combination with an aromatase inhibitor, whose l in combination with trastuzumab for meta-

menopausal women who had ‘HR+/HER2+’ disease had worsened despite previous treatment static cancer that does not respond to
breast cancer and whose disease had worsened with trastuzumab, should decide whether to hormones (hormone receptor-negative
despite previous treatment with trastuzumab. continue with the same therapy or consider an disease), and which got worse when
The results had indicated a benefit of Tyverb over alternative treatment. previously treated with a combination of
trastuzumab when each medicine was used Tyverb is a cancer medicine used to treat trastuzumab and other cancer medicines
together with an aromatase inhibitor. While there patients with HER2+ breast cancer. This means (chemotherapy);
are no new safety concerns with Tyverb, data on that a specific protein called HER2 (also known l in combination with an aromatase inhibitor

its benefit over trastuzumab in this patient as ErbB2) is present on the surface of the cancer (another type of cancer medicine) in women
population are currently being re-evaluated. cells. Tyverb is used in the following ways: who have been through the menopause, when
The detected errors were included in the l in combination with capecitabine (another the cancer is metastatic and responds to
prescribing information for Tyverb on July 30, cancer medicine) when the cancer is ad- hormones. This combination is used in
2018. However, these will now be removed while vanced or metastatic and got worse following women who do not currently need to receive
data are being re-analysed. In the meantime, the previous treatment including an anthra- chemotherapy to treat their cancer.
prescribing information will be amended to state, cycline and a taxane (other types of cancer Tyverb was originally granted a conditional
as before, that no data are available on the medicines) and following treatment of the marketing authorisation valid throughout the EU
effectiveness of Tyverb compared with patient’s metastatic disease with trastuzumab in June 2008 and was switched to a full marketing
trastuzumab in this combination in patients (another cancer medicine). ‘Advanced’ means authorisation on February 17, 2015.

74 | September 2019 Medical Writing | Volume 28 Number 3

Withdrawal of marketing authorisations for fenspiride medicines

May 24, 2019 – EMA’s safety committee these problems with fenspiride. In contrast, dation
(PRAC) has recommended that the marketing fenspiride medicines are used to treat non- w i l l
authorisations for fenspiride medicines be serious cough. Therefore, the PRAC considered now be
revoked, so the medicines can no longer be that these medicines should no longer be sent to
marketed in the European Union (EU). This marketed. the Co-ordin-
follows a review that has confirmed that these Fenspiride medicines are available as syrup or ation Group for
cough medicines could cause heart rhythm tablets and used in adults and children from the Mutual Recog-
problems. age of 2 years to relieve coughs resulting from nition and Decen-
The PRAC considered all the available lung diseases. In the EU, fenspiride medicines are tralised Proce-
evidence in its review, including case reports and available under various brand names (Elofen, dures – Human
nonclinical studies (including hERG channel Epistat, Eurefin, Eurespal, Fenspogal, Fosidal, (CMDh) to
binding). This included cases of QT prolon- Kudorp, Pneumorel, Pulneo, Еуреспал and make a decision
gation and torsades de pointes (abnormalities of Сиресп). about its implemen-
the heart’s electrical activity that may lead to The review of fenspiride was initiated on tation. The CMDh is
heart rhythm disturbances) in patients using February 14, 2019, at the request of France, responsible for
these medicines, results of laboratory studies, under Article 107i of Directive 2001/83/EC. ensuring harmonised
data from published literature and stakeholder At that time, the PRAC recommended that safety standards for
input. supply of fenspiride medicines be suspended as medicines authorised via
Heart rhythm problems can be serious and a precautionary measure while the review was national procedures across
occur suddenly, and it is not feasible to identify ongoing. Because fenspiride medicines are all the EU, Iceland, Lichtenstein
in advance the patients who may be at risk of licensed at national level, the PRAC recommen- and Norway.

EMA facilitates early engagement with medicine developers to combat antimicrobial resistance
May 24, 2019 – EMA has opened up an early Without a sustained effort to contain anti- and speeding up the development of anti-
dialogue through its Innovation Task Force microbial resistance, common diseases are microbial medicines, which is in line with
(ITF) to all medicine developers who work on becoming untreatable and lifesaving medical the European Parliament Resolution of
therapeutic approaches for the treatment or procedures riskier to perform. 13 September 2018 on “A European One Health
prevention of bacterial and fungal infections. Stimulating the development of new Action Plan against Antimicrobial Resistance”.
ITF is a forum for dialogue between regulators medicines to treat resistant bacterial or fungal Interested medicine developers are
and developers of innovative emerging therapies, infections is one pillar in the fight against this encouraged to complete the ITF briefing meeting
methods and technologies, in the early stages of threat, and a high priority for EMA and the request form and send it to itfsecretariat@
research and development. ITF is usually European medicines regulatory network. ema.europa.eu to discuss their development plans
reserved for innovative medicines. Given the The ITF will facilitate an early interaction and for medicinal products addressing bacterial and
growing threat to public health caused by broad-ranging discussion between innovators fungal infections.
antimicrobial resistance and the need for new and regulatory authorities,
treatments, EMA is inviting all developers which will help developers’
working on medicines for the treatment or orientation and subsequent
prevention of life-threatening microbial use of formal regulatory
infections to enter into early dialogue with the tools such as EMA’s
Agency to help strengthen the drug development scientific advice. The service
pipeline for new antimicrobials. is free of charge and any new
The emerging and steady increase of microbes medicinal product for the
that are resistant to antimicrobial treatments treatment of a life-
threatens the effective treatment of patients with threatening or debilitating
infectious diseases. According to a World Health fungal or bacterial infection
Organization (WHO) report, approximately would be considered for
700,000 people die from drug resistant infections discussion in the ITF.
globally each year, a figure that could rise to 10 This platform for early
million deaths globally per year by 2050 under dialogue will ultimately
the most alarming scenario if no action is taken. contribute to prioritising

www.emwa.org Volume 28 Number 3 | Medical Writing September 2019 | 75

Strengthening engagement between EMA and general practitioners

June 6, 2019 – The EMA and the two major Forum for Primary Care (EFPC), have signed a feedback from primary care to EMA are currently
organisations representing general practitioners joint statement committing to strengthening limited. Developing a strong working relation-
(GPs) and family physicians in Europe – the interaction between EMA and this important ship with this very large group of physicians aims
European Union of General Practitioners group of healthcare professionals. to:
(UEMO) and the European section of the World While EMA benefits from an existing frame- l help EMA gain a better understanding of how

Organization of Family Doctors (WONCA) – work of interaction with healthcare professionals medicines are being used in real life and the
and the major organisation representing primary – including physicians, pharmacists and nurses – potential impact of specific regulatory actions
care professionals in Europe, the European interactions with GPs and family physicians and on patient care;
l facilitate the incorporation of views and input

from GPs and family physicians into the

Agency’s activities;
l raise awareness amongst GPs and family

physicians of the role and activities of the EU

medicines regulatory network.
The statement includes a concrete action
plan to 2020 to guide EMA, UEMO, EFPC, and
WONCA in their joint work. Specific areas of
collaboration include involving GPs and
family physicians in EMA evaluation activities,
developing communication activities relevant to
GPs and family physicians, as well as exploring
options for further collaboration with existing
research networks in primary care, with a focus
on generating real-world evidence. The
action plan also identifies opportunities for
cooperation in regulatory science training.
The development of the joint statement
follows a workshop which took place in 2016
with representatives of GPs and family
physicians in order to explore new ways to
engage with these providers of primary care in
EU Member States and further involve them in
EMA activities.
Progress will be monitored and discussed
within the EMA GP/family physician expert
group and reported to the EMA healthcare
professionals’ working party.

Bacterial lysate medicines for respiratory conditions to be used only for prevention of
recurrent infections
June 28, 2019 – EMA is recommending that In the review, EMA’s human medicines com- The CHMP therefore recommended that use of
bacterial lysate medicines authorised for mittee (CHMP) considered the results of clinical the medicines for prevention can continue, but
respiratory conditions should only be used for the studies, data on side effects reported with these the companies must provide further data on safety
prevention of recurrent respiratory infections, medicines, and advice from an expert group on and effectiveness from new clinical studies
with the exception of pneumonia. This follows a infectious diseases. by 2026.
review that concluded that there are no robust Although data are limited, the review found Bacterial lysate medicines are made from
data showing that these medicines are effective at some evidence of effectiveness of these medicines bacterial cells that are broken down and are
treating existing respiratory infections, or for the in the prevention of recurrent respiratory tract intended to stimulate the immune system to
prevention of pneumonia, therefore they should infections and the safety profile is in line with recognise and fight infections. These medicines
not be used for these purposes. what is expected for this type of product. are taken by mouth (as capsules, tablets,

76 | September 2019 Medical Writing | Volume 28 Number 3

New treatment for children with type 2 diabetes

June 28, 2019 – EMA’s human medicines hypoglycaemia. Therefore,

committee (CHMP) has recommended granting there is a medical need for
an extension of indication to Victoza (liraglutide) alternative treatment options
to include the treatment of children and for children and adolescents
adolescents aged 10 years or older with type 2 with type 2 diabetes.
diabetes. This medicine is already approved for Victoza is the first non-
use together with diet and exercise in adults with insulin, besides metformin, to get
type 2 diabetes, on its own or as an add-on to a positive opinion for paediatric
other diabetes medicines. use for type 2 diabetes. The active
Type 2 diabetes is a chronic disease in which substance in Victoza, liraglutide, is an
the pancreas does not make enough insulin to ‘incretin mimetic’. This means that it
control the level of glucose (sugar) in the blood acts in the same way as incretins, a group
or when the body is unable to use insulin of metabolic hormones that stimulate an
effectively. It can lead to serious complications if increase of the amount of insulin released by
a person does not receive treatment. According the pancreas in response to food. This helps with
to the WHO, type 2 diabetes has increasingly the control of blood glucose levels. Liraglutide
been reported in children and adolescents has been used in adults for approximately ten
recently, so much so that in some parts of the years, so there is an extensive amount of data
world type 2 diabetes has become the main type available in particular with regards to safety.
of diabetes in children. The efficacy and safety of Victoza in children The results of the
The recommended treatment for paediatric and adolescents was investigated in a placebo- trial demonstrated that the safety profile of
type 2 diabetes is similar to that in adults, with controlled trial with 134 patients with type 2 Victoza in this population is comparable to that
emphasis on a step-wise approach starting with diabetes aged 10–17 years. This study was carried in adults. The most common side effects were
lifestyle modifications, particularly healthy eating out in accordance with a Paediatric Investigation nausea, vomiting, diarrhoea, headache and
and exercise, followed by the use of a single Plan, which was agreed by the Agency’s abdominal pain.
medical therapy and later by two therapies in Paediatric Committee (PDCO). The opinion adopted by the CHMP is an
combination. The aim is that the patient achieves The study compared patients in the liraglutide intermediary step on Victoza’s path to patient
and maintains low levels of glucose in the blood group with a placebo group over 26 weeks. access in this new indication. The CHMP
in order to prevent long-term complications. Patients treated with Victoza, with or without opinion will now be sent to the European
Currently, the only two approved treatment insulin, experienced a clinically relevant Commission for the adoption of a decision on an
options for paediatric type 2 diabetes patients in reduction in the levels of glycated haemoglobin EU-wide marketing authorisation. Once a
most countries are metformin and insulin. (HbA1c) that is measured via a blood test to marketing authorisation has been granted,
However, more than half of young patients do not evaluate average blood sugar levels in a patient decisions about price and reimbursement will
achieve glycaemic control on metformin alone, over a period of weeks or months. A higher take place at the level of each Member State,
even when combined with lifestyle interventions, number of patients experienced hypoglycaemic taking into account the potential role/use of this
and treatment with insulin has considerable side episodes in the liraglutide group than in the medicine in the context of the national health
effects such as weight gain, or a high risk of placebo group irrespective of prior insulin use. system of that country.

granules/powder for making up an oral mixture

or drops), dissolved under the tongue (as tablets),
inhaled through the nose (as a liquid) or given by
injection into a muscle or under the skin.
Bacterial lysate medicines are sold under
several brand names including Broncho Munal,
Broncho Vaxom, Buccalin, Immubron, Immu-
cytal, Ismigen, Lantigen B, Luivac, Ommunal,
Paspat, Pir-05, Polyvaccinum, Provax, Respivax
and Ribomunyl.

www.emwa.org Volume 28 Number 3 | Medical Writing September 2019 | 77

Regulatory Matters
Trends in medical writing

Changes in the regulatory landscape and changes Medicines and Healthcare Products Regulatory
in our professional environment make this an Agency. From its new headquarters in Amster- SECTION EDITOR

●
exciting time to be part of the regulatory medical dam, the EMA has maintained core public health
writing community. It is a time when new work, as well as the evaluation and supervision ✒ Jennifer Clemens
[email protected]
opportunities are presenting and when, like never of medicines. Some other activities, such as
before, the medical writing community has guidance development and transparency
chosen to come together to conscientiously shape initiatives, have been temporarily scaled back.1 trial participants in support of their critical
our professional landscape. As this happens, we Now is no time for health agencies and the decision-making process.
recognise and value well-established approaches, pharmaceutical industry to let up on proactive
reinforce innovations in practice, and secure the measures such as allowing for preparation of The professional landscape
future for our profession. slightly different sets of regulatory documents for Leaders in the American Medical Writers
the two agencies when they part ways. Association (AMWA) and the European Medical
The regulatory landscape The Food and Drug Administration (FDA) Writers Association (EMWA) work closely with
Medical writers have been adapting to changing in the United States has launched a pilot medical writing industry executives to assess the
regulatory directives for decades. This history of programme exploring real-time data review for state of the profession and to develop plans to
flexibility positions us well for the latest evolutions. oncology marketing applications (called, of ensure vibrant growth and development of our
No place is more dynamic than China, where course, the Real-Time Oncology Review pro- workforce. Activities kicked off at the AMWA
changing regulatory procedures, ICH adoption, gramme).2 The FDA also newly sponsors annual conference in 2018 included systematic
and a potential marketplace of historic pro- participation in the written preparation of its group conference calls, surveys of organisational
portions make the clear, concise, and compliant Assessment Aids for marketing applications. The members, and the development of new and
communication of all aspects of drug devel- two programmes require new ways of working innovative educational programmes. Our efforts
opment essential. Beginning with the clinical trial with data and information, and they provide a aim to prepare the next generation of medical
application, documentation increasingly plays a directional signal as to possible modifications to writers, develop leadership capabilities in these
critical role in a shortened approval timeline. An the review processes of the future. future standard-bearers, build partnerships in
example? In China today, if no comments have Regulators also continue to emphasise the technological advances for regulatory communi-
been received from regulatory authorities importance of meeting the needs of trial par- cation, and quantify the value of medical writing
60 working days after the written submission of ticipants. We see moves towards more trans- to the drug-development industry.
a clinical trial application, that trial may move parency for clinical documentation and more We also sense within medical writing organi-
forward. With a plan to implement eCTD in health literacy materials. These developments sations an increase in adoption of competency
2020, review and approval of marketing appli- allow medical writers to expand our scope and guides such as the “Pharmaceutical Medical
cations will likely move more quickly as well. skills, and they offer opportunities to explore Writing Competency Model”3,4 in an effort to
In Europe, pending exit of the United King- how technology can support the development of establish standard expectations for writing
dom from the European Union, we anticipate regulatory deliverables. We see for informed skillsets. This model, first published in 2011 and
continued changes with the European Medicines consent, in particular, a need to re-evaluate the updated in 2017, helps establish hiring and
Agency (EMA) and the United Kingdom’s content and volume of information provided to performance evaluation criteria and also can be

78 | September 2019 Medical Writing | Volume 28 Number 3

aligned with a training plan for career devel- important. We simply need to go after our 2. US Food and Drug Administration. Real-
opment – all in support of medical writing. medical writing goals with determination…and Time Oncology Review Pilot Program.
Another growing option for establishing the right attitudes and right aptitudes. 2019 [cited 2019 July 1]. Available from:
credibility is the Medical Writer Certified https://www.fda.gov/about-fda/oncology-
(MWC®) credential, earned through an AMWA Joan Affleck, MA, MBA, ELS center-excellence/real-time-oncology-
exam.5 The credential acknowledges core Executive Director, review-pilot-program.
competencies in medical writing and a com- Head of Medical Writing 3. Clemow DB, Wagner B, Marshallsay C, et al.
mitment to continued professional development. Merck & Co., Inc. (MSD outside the USA) Medical writing competency model -
Kenilworth, NJ, USA section 1: functions, tasks, and activities.
Conclusion [email protected] Ther Innov Regul Sci. 2018;52(1):70–7.
Our trend line in medical writing points upward 4. Clemow DB, Wagner B, Marshallsay C,
and outward. Today we can seize immediate et al. Medical writing competency model -
opportunities to redefine our value and expand section 2: knowledge, skills, abilities, and
our scope of work in ways that highlight our References behaviors. Ther Innov Regul
scientific and clinical expertise, regulatory 1. Van Arnum P. Pharma and Brexit: What Sci. 2018;52(1):78–88.
acumen, communication skills, and project happens next? DCAT Value Chain Insights. 5. American Medical Writers Association.
management mastery. With the right vision and 2019 May 14 [cited 2019 Jun 25]. Available Certification. 2019 [cited 2019 Jun 20].
execution, this exciting – even exhilarating – time from: https://www.dcatvci.org/5960- Available from:
in our profession can turn out to be historically pharma-and-brexit-what-happens-next. https://www.amwa.org/page/MWC.

Medical Communications
and Writing for Patients
SECTION EDITOR

●
✒ Lisa Chamberlain James
[email protected]

patients and the healthcare industry) in the UK

and internationally, to bring the patient voice
into the healthcare journey, addressing issues
that affect both specific and cross-patient
communities, as well as issues affecting the
healthcare industry. She is very well connected,
and her work has taken her to, or involved her
with, organisations from the Netherlands,
France, Austria, Portugal, the Czech Republic,
Romania, Northern Ireland, Switzerland,
Germany, Spain, England, Poland, and the
Editorial present a feature article I co-wrote with Trishna USA, among others.
Dear all, Bharadia (Lay summaries and writing for We both felt that the time was right to look
The more eagle eyed among you will have patients: Where are we now and where are we at what has happened in the arena of writing for
noticed that we are changing the title of this going? p. 46). Given the topic, we thought it best patients, and we offer suggestions for where the
section to “Medical Communications and to present it as an open access feature article, industry might be heading in this regard. I hope
Writing for Patients”. Not the shortest of titles, rather than running it in our members-only that you enjoy the article. As always, I would be
I know, but hopefully it is a more accurate section. delighted to hear any thoughts, suggestions, or
reflection of the content that will be included As a The Spark Global consultant, Trishna proposals for articles.
in the section. works with multiple stakeholders (including Bestest,
In this issue of the journal, I am delighted to pharma, patient associations/charities, clinicians, Lisa

www.emwa.org Volume 28 Number 3 | Medical Writing September 2019 | 79

In the Bookstores
The Biomedical Writer of the study. They also
SECTION EDITORS
Yellowlees Douglas and suggest that researchers

●
Maria B. Grant classify their study by its
✒
Alison McIntosh
Cambridge University outcomes – i.e., as [email protected]

●
Press, 2018 “incremental”, “first ever”,
✒
Stephen Gilliver
ISBN-978-1-108-40139-5 “incidental/dramatic”, or [email protected]
Paperback “a paradigm shift” (accept-
£22.99 206 pages ing that outcomes often
straddle more than one their work through a thorough literature search.
category) before even They recommend the use of search algorithms in
Yellowlees Douglas is a consult- writing an outline. They Google Scholar and PubMed to ensure that all of
ant on writing and organisations point out that this will also the background on the topic is captured and to
and an associate professor in the be useful in promoting the highlight gaps in current knowledge and/or
Center for Management Com- paper (e.g, through social practice. The authors then take each section of
munication at the University of media) post-publication. the manuscript in turn and provide very detailed
Florida, USA. Maria B Grant is a I found the “Progressing descriptions and advice on how they should (and
professor of ophthalmology at Your Career” section at the should not) be constructed. The section on
the University of Alabama, USA who has end of Chapter 3 troubling, as it could be writing the introduction takes 15 pages, reflecting
authored more than 200 peer-reviewed interpreted as encouraging writers to flout the importance the authors place on getting this
publications. The book is targeted at academic ICMJE and GPP3 recommendations. This right. The authors’ suggestions to create a basic
researchers rather than professional medical section is ostensibly about mentorship, but in my outline that you can gradually expand, to use the
writers. opinion, readers could replace “mentor” with introduction to highlight where the gaps in
This small paperback consists of seven “sponsor”. In respect of review papers it says: research are, to ensure that the methods section
chapters each of which begins with a bullet point “Usually, rather than write the manuscript covers the Who, What, When, Where and How
list of learning points and is interspersed with themselves they enlist…someone they mentor of the study, to stick to reporting data in the
‘Between the lines’ and ‘Snares to avoid’ to collaborate with them on the review.” For the results section and keep commentary on those
information boxes – opportunities for a deep dive word collaborate substitute write. And “Your findings for the discussion all reinforced my
into some of the topics covered in the chapter. mentor’s name may well get the paper published beliefs about the most efficient way to write a
The first chapter (Writing: The most vital – and at a good journal.” This is the type of behaviour manuscript. The authors make the very good
neglected – skill) serves as an introduction to the that the pharmaceutical industry has rightly been point that this is what journal editors and
book and its authors. criticised for and which prompted reviewers are looking for – and
Chapter 2 (Writing for your reader’s brain) is the development of ICMJE and GPP The authors deviating from that pattern is likely to
very different in style to anything I’ve read in guidelines. These authors acknowl- make some result in manuscript revisions and
other textbooks on medical writing. It takes an edge the perniciousness of these important publication delays.
academic approach to how we read – from basic arrangements – in the process making Other high points of this chapter
word recognition to recalling content – and a very valid observation about the
suggestions for were the “Making discussions more
provides tips on how to organise sentences and way in which they affect women’s ensuring that accessible” section (which included
paragraphs to have the greatest impact. For me, career progression – yet, disap- writers the BMJ’s suggested structure for
this chapter underlined two important principles. pointingly, encourage their readers to understand and discussions) and an explanation of the
The first is that papers must be readable to have play the game rather than change the terms association, correlation, and
impact – good research can be obscured by game.
properly convey causation. There were some low points
“clunky” writing. The second is that writers Chapter 4 (Getting published: the context of in the chapter for me, however. Some
should always ask a copy editor to look at their manuscripts, journals and sub- their work of the subsections were just too
work before submitting. missions) is by far the longest chapter through a theoretical (in particular, the use of
One of the learning points for Chapter 3 in the book (at 47 pages) and for me gambits in constructing the intro-
(Before you begin: getting to So what? and Who was the most important. The chapter
thorough duction). Some of the subtitles were
cares?) is to anticipate potential objections or has 10 sections. It starts with some literature search. just too contrived: titles such as
rejections as you are writing. I think that this is great practical advice on targeting “Manage the Scylla and Charybdis of
good advice. To this end, the book’s authors journals and familiarising yourself with their style discussions” and “Running the gatekeeper gaunt-
remind writers to use appropriate guidelines and author guidelines. The authors make some let when submitting” seemed to run counter to
(CONSORT, PRISMA, STROBE, STARD, and important suggestions for ensuring that writers the advice in the chapter. Once again, the lack of
STREGA) to avoid compromising the reporting understand and properly convey the context of encouragement to write collaboratively, with all

80 | September 2019 Medical Writing | Volume 28 Number 3

authors earning their place on the by-line, is the tools to deal with them. The authors caution be useful in any market. I very much liked the
disappointing. On the one hand, the authors are writers to expect to fail at their first attempt and authors’ practice exercises for writing press
encouraging researchers to check and act on provide strategies for responding constructively releases – gradually distilling down the key points
journal requirements, and on the other they say: to criticism of the manuscript. of a research publication until the most
“… you are writing the paper exclusively because Chapter 6 (Collaborative writing: pass the significant and newsworthy findings remain.
the invited [my emphasis] senior author has baton) – which covers preparation of both grant They list nine criteria by which the news-
delegated its writing to you” – behaviour that in applications and research papers – is very nicely worthiness of research findings can be assessed:
most cases would prevent a journal publishing a done. It suggests the type of expertise that you impact, significance, controversy, prominence,
paper. I also took issue with three of the other- need to have in your writing team to complete the the unusual, timeliness, currency, usefulness, and
wise excellent takeaways from this chapter: paper and accurately describes the challenges of educational value. If your findings encompass
“consider publishing negative data” (many ensuring that everybody’s views are considered, one or more of these, its should be possible to
journals actively encourage this now in order to and a consensus arrived at before submission. I write a release that garners interest among the
recognise the contribution made by patients wasn’t impressed by the authors’ suggestion that press. The authors remind readers to check with
taking part in the study); “filter the data you all potential authors complete a light-hearted their publisher before issuing a press release and
report in your results section to highlight only questionnaire to identify strengths and weak- about the necessity to publicise the research and
your most significant findings” and “highlight nesses as a writer, or their categorisation of not any product that was used in the research.
your most important finding in the opening different types of writer. The chapter does, The ‘Snares to avoid’ section in this chapter
paragraph of your discussion” (GPP3 encourages however, include some pertinent advice on concerns ‘pay to play journals’: it is clear from
authors to be guided by the objectives/endpoints setting and enforcing deadlines and on different their description that the authors are referring to
of the study, with the emphasis placed on the ways of communicating with the team during the predatory journals here, and I think it is a shame
primary outcome). writing process. I heartily endorse the authors’ that they didn’t stick to this terminology. There
Chapter 5 (Getting funded: applying for recommendation for face-to-face meetings are reputable journals that charge a fee for open
grants) will be of interest to EMWA members whenever practicable (especially for discussing access publishing and it would be a shame if
who work in this area, or who want to work in contentious or difficult matters). I found their researchers were discouraged from using them
this area, but is outside my own experience. The comments about email exchanges interesting and because of a misunderstanding. I also think that
authors reiterate their key messages for writing enlightening. In this context, emails should be this section would have been better included in
manuscripts: prepare well – ensure that you brief, have a clear subject, ideally state the main Chapter 4.
understand what type of funding is on offer and purpose in the opening sentence and certainly in This book is not an easy read – you need to
what it can be used for; anticipate the likely the first paragraph, and seek to conclude a set time aside and study its contents. It is a book
outcomes of your research and don’t over- (or discussion not to start one. This chapter allays that some medcomms agencies may appreciate
under-) sell it; understand the needs of your some of my concerns that the authors are for its insight into how people take in and
audience; clearly identify gaps in current sanctioning ghost writing and guest authorship, understand what they are reading, and how you
knowledge and practice that the research will and I think that it is a shame that it was not placed can organise your writing to optimise the delivery
address; and prepare an initial outline of the earlier in the book. of your messages. Aimed, as it is, primarily at
application before starting to write. The authors Chapter 7 (Communicating with the public) academics, however, this book is not a general
encourage writers to think of their grant deals with writing press releases and materials reference text for professional medical writers.
application as a business plan that leaves the such as consent forms and lay summaries for the Reviewed by
reviewer with no unanswered questions and public to use. The preamble to the guidance on Jane Tricker
clearly demonstrates that you have considered all writing lay materials is very US-focused, but the Elmcroft Editorial Services Ltd
the problems that you might encounter and have step-by-step guidance itself is general enough to [email protected]

Save the date:

FILLER EMWA Conference in
the Czech Republic

May 6 to 9, 2020
PRAGUE
https://www.emwa.org/conferences/future-conferences/

www.emwa.org Volume 28 Number 3 | Medical Writing September 2019 | 81

Getting Your Foot in the Door
SECTION EDITOR
Editorial
The Vienna Conference is done and dusted. But the aftermath is so rewarding, as my knowledge has
broadened and my network has widened. It was a joy to meet old colleagues but also get to know
many people who are new to medical writing.
●
✒ Raquel Billiones
[email protected]

In this Getting Your Foot in the Door (GYFD) edition, I am especially happy to feature two
testimonials from EMWA newbies. I want to thank Adriana for her constructive feedback and hope
we can use her ideas for future EMWA events.
I met Sanjukta at an EMWA ambassador event in Munich in 2018 and was really pleased to her
again on Vienna. I also want to congratulate her on getting her foot in the door – she recently started
a regulatory affairs position.
See you in Malmö!
Raquel Billiones

Wanted: A “medical writing for dummies” manual

Vienna 2019 was my first EMWA conference. a new career was a bit daunting and I needed to but it also felt like unused potential. These people
Coming from 8 years in academia and this event know more. I saw in the programme that there are experts at their particular fields, and while it
being my first experience into the medical writing was a session entitled Getting into Medical is interesting to know their stories, we were there
field, what first struck me was the friendliness and Writing (GIMW) at the beginning of the to know how to get started ourselves. I want to
genuine desire to network felt throughout the conference and an Introduction to Medical know what I require to become a medical writer,
conference. Networking is taxing at the best of Writing (Intro MW) at the end. I was confused how to improve my skills continuously and
times, but here it was built in into the fabric of the by the similarity of the names but decided to become an experienced professional. Afterwards,
profession. I was surprised to learn many of the attend both and learn as much as I could. there was an individual CV clinic with two
attendees were freelancers; freelancing was a new At GIMW, four medical writers of different experts which had to be arranged beforehand.
reality that I had never thought of before. Talking backgrounds presented their personal experiences Again, I felt there would have been more benefits
with freelancers gave me a new perspective but of how they became medical writers and what from a short presentation on the subject instead.
the lack of guidance and mentoring starting out they currently specialised in. It was informative On the very last day, there was the Intro MW
session. Magali Le Goff presented a condensed
picture of medical writing: what it is, what are the
skills needed, and how to tailor your resume. I
learned new things and consolidated my

Know
knowledge of others I had known before or

Learn
learned throughout that week at the conference.
However, it felt disjointed to have that session as
What is
medical writing
? Basic skill sets
unications
Medical Comm
y Writing
and Regulator

Figure 1. The medical writing for dummies method:

1. Know: know how medical writing is divided into medical
communications and regulatory writing, what are the specifics
to each field.

Improve
2. Learn: what do you need to learn to be a medical writer (text

Present
editing, language, relevant regulations and guidelines, etc.)?
3. Present: as an aspiring medical writer, how do you present
Continuous yourself to potential clients or employers, what are the rules to a
é
CV and Resum training good CV?
4. Improve: as a medical writing professional, how do you improve
your skills, learn new ones, share your knowledge?

82 | September 2019 Medical Writing | Volume 28 Number 3

the very last one of the conference, when it
should have been the first.
Solely from my point of view as a newcomer
wanting to learn more about medical writing, the
Intro MW should have been the first event,
followed by the tools and skill sets necessary to
become a good professional. Within that scope,
I would also like to know more how to get
involved in EMWA. There were separate sessions
such as the freelance business forum or the
education committee, as well as other oppor-
tunities I heard from various people, but it would
have been useful to have a centralised event
where I can learn about volunteering,
contributing to the official journal, creating a
webinar, know about other (non-EMWA) online
courses that helped other newcomers or even
give a workshop. Finally, ending with a CV clinic
presentation would complete the Medical
Writing for Dummies Manual that would be
invaluable for anyone entering the field (Figure conference was that EMWA was made by its and present these sessions to
1). members, for its members. And indeed, the better give a head start to its newest members.
I do understand the EMWA conference is a potential is there, with talented speakers willing
large event and that it is logistically challenging to volunteer their time and knowledge to teach Adriana Rocha
to schedule rooms and speakers. That being said, others. A centralised medical writing for [email protected]
one constant reminder throughout the dummies committee would be able to structure

How the EMWA community helped me shape my career

During the last years of my work as a senior medical writer. I started to look for job of hope and positivity defined my days at the
postdoctoral researcher, I realised that much of opportunities in the field of medical writing and conference. Adding to this, the expert
my explorative self was somehow bound by a was invited to the next set of surprises. Every time workshops in global regulatory documentation
false sense of security and procrastination to try I applied for a job, one aspect that overruled all have been the most enlightening aspects of the
a career change. It took me time, but I started other seemingly important attributes was the conference. The depth of the technical input
to slowly peep “out of the box” to find a way for word experience. Was it not evident from the and high standard of the workshops were
reorientation. To start, I tried to take different articles that I published that I could probably indeed noteworthy. Group discussions and
types of courses ranging from project have some intellectual capacities? Sadly, the laughing back at errors, but above all, learning
management, agile methods to social media scientific articles that resulted from multi- and exploring a relatively new avenue has been
and discovered a short one-day introductory institutional collaborations were reduced to just more than exciting for me. With EMWA, I truly
course on medical writing at the Munich numbers. I was even advised to completely strike feel to be a member of a community of
Biotech Cluster. Much to my surprise, this one- them off from my CV, leaving me no chance for individuals who are trying to help each other
day course with Raquel Billiones and Abe a throwback. I gradually realised that I needed and foster hope and success in an otherwise
Shevack, both senior members of EMWA, had something more concrete and found the 48th highly volatile and competitive field. Added to
actually laid the foundation of where I stand EMWA conference at Vienna knocking at the this, I realised that mentioning my participation
today. It was through this course that I came to door. I decided to attend the conference and at the conference on my CV kindled more
know about EMWA. enrolled for workshops that are part of the positive responses from recruiters. As I write
This, in fact, was the source of light in the EMWA professional development programme. I this article today, I feel more confident to find
dark, seemingly never-ending tunnel. I enrolled must say, this has been an extremely fulfilling a new position in regulatory documentation, to
myself for an extensive advanced training in decision. be able to define my new professional identity,
Life Science Management at ATV Munich, to The friendly, open spirit for professional and above all “to strive, to seek, to find, and not
learn the fundamentals of clinical research and networking was what I found most interesting at to yield”.
regulatory affairs. With the training, I found the EMWA conference. Smiles from unknown
quite some overlap between my updated members simply coming to share a word, Sanjukta Dey-Irmler, PhD
background and the professional profile of a technical suggestions, and above all, the feeling [email protected]

www.emwa.org Volume 28 Number 3 | Medical Writing September 2019 | 83

Veterinary Medical SECTION EDITOR

Writing ●
✒ Karim Montasser
[email protected]

Go, vets. Go!

Like many medical writers, I started in another commonly not powered for clinical safety bring the necessary treatment effect – with the
career first. For me, it was practising veterinary endpoints, are subject to bias, and could be seen very potent drug mycophenolate. Still, our dog
medicine in a clinic, then going into clinical as hypothesis-generating only. deteriorated. A former colleague from my clinical
research in humans, and then on to medical days told me that I should not give up though;
writing. Designing clinical trials, sample size Christmas and immuno- she had successfully treated dogs the clinic had
calculations, and critically analysing literature suppressive medication given up on with azathioprine. So, which of the
became my passion along the way. But the more To give you a practical example: On Christmas three therapies should be selected – the one I had
I learned, the more I realised that in veterinary Eve in 2017, our dog Estelle became ill and was good experience with in the past, the one my
medicine, we often base our treatment decisions diagnosed with autoimmune haemolytic anaemia. friend had good experience with, or the one the
on very limited information. Naturally, there is During my early years at the clinic, I treated this veterinary clinic was currently using? And soon
less money available for clinical studies in disease with dexamethasone and cyclosporine. the next question arose: Will our dog have a
veterinary medicine compared to human Now, 20 years later, in a very modern and chance to survive at all? Despite all the supp-
medicine, so published studies often involve low prestigious Munich clinic, our dog was initially ortive therapy, our dog was suffering trem-
subject numbers. Such small studies are treated with prednisolone, and – as this did not endously, but on the other hand, she was only 6

84 | September 2019 Medical Writing | Volume 28 Number 3

years old, so we did not want to give up easily as The more I learned, the more References
long as there was a fair chance for survival. I realised that in veterinary 1. Swann JW, Skelly BJ. Systematic review of
prognostic factors for mortality in dogs with
medicine, we often base our
What about evidence-based immune-mediated hemolytic anemia. J Vet
medicine? treatment decisions on very Intern Med. 2015;29(1):7–13.
I did what every medical writer would do – a limited information. 2. WMA Declaration of Helsinki – Ethical
literature search. But all I found were poor quality principles for medical research involving
studies involving only a few dogs with insufficient human subjects [cited 30 Jun 2019].
length of follow-up (mostly only 30 days) and Available from: https://www.wma.net/
one meta-analysis about my dog’s condition that forming an EMWA veterinary medicine special policies-post/wma-declaration-of-helsinki-
included 380 dogs, though it did not refer to the interest group (vet-SIG). As is so often the case ethical-principles-for-medical-research-
different therapies.1 My questions – which therapy with good ideas – somebody else had it first. involving-human-subjects/.
is the best and what are the 1-year survival rates? Sandra had gathered some people with interests 3. Ohmann C, Banzi R, Canham S, et al.
– could not be answered from existing literature; for workshops and Tiziana von Bruchhausen, the Sharing and reuse of individual participant
it did not even give me a hint. EMWA president at that time, had the idea to data from clinical trials: principles and
In Germany, veterinary medicine is one of the form a vet-SIG group. Tiziana was instrumental recommendations. BMJ Open.
most demanding university degrees, and yet our in putting the strings together, and finally, the first 2017;7(12):e018647. doi:
treatment decisions are often based on personal vet-SIG meeting was held in May this year in 10.1136/bmjopen-2017-018647.
experiences, beliefs, and limited data, rather than Vienna. 4. ICMJE. Recommendations for the conduct,
good quality evidence-based medicine. This This issue is about trends in medical writing reporting, editing, and publication of
should be unacceptable. – I truly believe veterinary medical writing can scholarly work in medical journals. 2018
become a new trend. And with the vet-SIG group [cited 20 Jun 2019]. Available from:
There are always options headed by Cemile Jakupoglu and Karim http://www.icmje.org/icmje-
In veterinary medicine, it would be utopian to Montasser, EMWA can be spearheading the field. recommendations.pdf.
ask for large-scale randomised controlled trials There are a myriad potential topics the group can
powered for clinical endpoints and registries with cover, for example:
thousands of patients as it is done in human l Enhancing the awareness of veterinary

medicine; there would simply be no funding for medical writing Beatrix Doerr
it. Yet, as vets, we have learned to be creative and l Enhancing the training and hence quality in [email protected]
work with what we have. Indeed, there are several veterinary medical writing
ways to improve research and the reliability of l Fostering clinical research in veterinary

outcomes with little or no money, e.g.: medicine

l Research Registration and Publication and In conclusion, the vet-SIG can help students
Dissemination of Results as stated in the get into medical writing, can help medical writers
Declaration of Helsinki2 to become good “veterinary medical writers”, and
l Data sharing, as practised in human can therefore help practising veterinarians make
medicine3,4 informed decisions, ultimately helping animals
l Using data from practice management soft- receive better treatment.
ware. This option is already used for epizootic These are giant tasks – so no pressure, just a
diseases, and there is one current pilot project huge thank you to the group for their willingness
with the University of Hannover (personal to make a difference.
communication from VETERA). So, let’s go vets!
But what was I to do as an individual that has
been out of veterinary medicine for 20 years? I Acknowledgement
was thrilled when I learned about the webinar I would like to thank Cemile Jakupoglu and The author with her dog Estelle,
“Veterinary Medical Writing” by Sandra Karim Montasser for their review and revision who had to be put to sleep
Goetsch-Schmidt and soon had the idea of and Jessica Lin for her language editing. 8 weeks after disease onset.

www.emwa.org Volume 28 Number 3 | Medical Writing September 2019 | 85

Medical Devices SECTION EDITOR

●
✒ Kelly Goodwin Burri
[email protected]

Editorial device writing at EMWA. Starting out as a for Medical Devices, I would like to update
Medical devices should certainly be included medical writer in 2004 the job fascinated me, you on the lively discussions that took place
on any list of trends in medical writing. That but I had my doubts about whether it was a during the expert seminar series in Vienna.
impression was only reinforced by the strong good fit for someone with an engineering and I also want to thank Beatrix Doerr for her
interest in device writing evident at this year’s orthopaedic research background. Writing for many quality contributions as the previous
EMWA spring conference. The three medical pharma was clearly the training focus at my section editor. I hope to continue her work
device workshops on offer were fully booked first EMWA conference back then, but in with the same commitment to raising
and the expert seminar series was well- 2019, I am happy to say I have found my awareness about the exciting world of medical
received. On a personal note, I was thrilled to perfect medical writing niche! device writing.
see the growing opportunities for medical In my first contribution as section editor Kelly Goodwin Burri

Expert Seminar Series: Updates from the medical device industry

The first expert seminar series on medical l Medical devices incorporating an ancillary differences in the risk-based classification of
devices was offered following on the resounding medicinal product. medical devices between the three regions. With
success of the Medical Device Symposium held the EU MDR implementation, approvals in
at the 2018 EMWA Conference in Barcelona. In both cases, the combination products will Europe are expected to become more difficult. In
The session included three presentations from need to comply with the European medical contrast, the US and Japan are making efforts to
industry experts and concluded with a panel device regulation (MDR) or the in-vitro harmonise their approaches that could
discussion. diagnostic regulation. This adds new require- potentially speed up the approval process in these
ments, including involvement of a notified body, regions. It was interesting to learn that for
Drug-device combination for products that previously would have primarily Japanese submissions there are no guidance
products: regulations and followed the pharmaceutical approval route. documents available, and the process depends
documentation The result is increased regulatory burden for both heavily on the individual reviewer assigned. It is
Mr Viky Verna (Vice-president, confinis ag, medicinal products and medical devices. essential to have local staff to support Japanese
Switzerland, and formerly employed at the US Innovation in combination products is submissions. Ms Stieler also recommended to
Food and Drug Administration) kicked off the occurring at a rapid pace. The evolving regulatory have consultations in parallel with the US and
session with a presentation of the intricacies of framework and expected industry growth present Japan whenever possible rather than expecting
regulations for drug-device combination prod- a unique opportunity for medical writers with an Japan to accept the position of US regulators.
ucts. The definition of combination products understanding of both the pharma and medical Overall the presentation provided useful insights
differs by regions but can be generally defined as devices worlds. Watch this space as more for medical device writers supporting global
a product consisting of two or more regulated regulations and guidance are expected to come. submissions in these three regions.
products. Think of transdermal patches for drug
delivery, inhalers, or pre-filled injection pens. In Medical device approval in Clinical evaluation,
the United States these products follow a single Europe, US and Japan: PMS/PMCF – Requirements
regulatory pathway with specific requirements Similarities and differences for plans and reports
determined by the product’s primary mode of The second session of the morning featured Ms requirements with impact on
action (PMOA). The PMOA is the most Myriam Stieler (Director Medical Affairs, medical writing
important therapeutic action of the product. In BIOTRONIK AG, Switzerland) comparing the Ms Susanne Gerbl-Rieger (Director Clinical
contrast combination products do not have their medical device approval processes in Europe, US, Audit, TÜV SÜD, Germany) presented the
own separate regulatory pathway in Europe. and Japan. The responsible parties providing perspective of a notified body in her talk on
Such products are regulated as either a device or approval in the three regions are the FDA clinical evaluation and post-market surveillance
medicinal product (drug) according to the (specifically the Center for Devices and Radio- activities of interest for medical writers. She
principle intended action (similar to the PMOA) logical Health) in the United States, the notified began with an important disclaimer – expect
resulting in two main regulatory pathways: bodies in Europe, and registered certified bodies many changes still to come. Many guidelines and
l Medicinal products with a medical device or the Pharmaceuticals and Medical Devices common specifications are still being written, so
component Agency in Japan. There are also some slight this is a constantly evolving space. She strongly

86 | September 2019 Medical Writing | Volume 28 Number 3

recommended to read the MDR – all of it – and and clinical performance, and the post-market were raised including the EUDAMED (the
to keep monitoring for new developments as clinical follow-up plans and reports. Ms Gerbl- European Databank on Medical Devices),
different aspects of the regulation are imple- Rieger also emphasised that manufacturers are transparency issues for medical devices, and the
mented. In particular, the common specifications not the only ones forced to adapt to the new use of registries to support post-market clinical
for clinical investigations, clinical evaluation, and regulations. Annex 7 of the MDR describes the follow-up requirements. EUDAMED will
post-market clinical follow-up, when finalized, specific responsibilities and requirements for the eventually serve as a repository for results of
will provide more information and important notified bodies under MDR, and the impact on medical device studies, but it will take time until
guidance for medical writers. She stressed that notified bodies is significant. The increased a large number of results are there. From an
quality counts, and there are many aspects for resources needed to comply with MDR have industry perspective, a consequence of MDR
compliant medical writing. It will be essential for resulted in an expansion of the resources at TÜV implementation could be a risk that small and
medical writers to be involved in the overall SÜD. They have almost doubled the size of their innovative companies will not be able to afford
process of the clinical evaluation, and team to support the duties required under MDR. to bring new products to the market. Overall the
experienced medical writers can make an audience was very engaged, and the discussion
important contribution in the creation of key Panel discussion continued well beyond the allotted time…only
documents including the clinical evaluation plan Beatrix Doerr and Art Gertel joined the speakers ending when we were finally asked to leave the
(which includes a clinical development plan), for the final expert panel discussion moderated room so that it would be ready for the next
clinical evaluation report, the summary of safety by Racquel Billiones. A wide range of topics sessions.

Save the date:

EMWA Conference in
the Czech Republic

May 5–9, 2020 PRAGUE

https://www.emwa.org/conferences/future-conferences/

www.emwa.org Volume 28 Number 3 | Medical Writing September 2019 | 87

My First Medical Writing
Editorial
In this edition of My First Medical Writing, we channels, and then became postdoc at the European developing her medical writing skills. It has been
welcome one of the first articles written by Molecular Biology Laboratory in Rome, Italy, to a pleasure working with her, seeing her grow day-
aspiring medical writer Mayya Sundukova. A study pain mechanisms and develop tools for by-day from constructive feedback, and now
physicist by training, Mayya pursued her PhD in neuroscientists. Now, she is exploring several career publishing her first article in Medical Writing.
neuroscience in SISSA, Italy, studying ion opportunities in academia and industry and Evguenia Alechine

SECTION EDITOR
Local photoablation of nerves to
treat chronic pain ●
✒ Evguenia Alechine
[email protected]

Chronic pain is bad, but no pain temperature. Certain mutations in NGF lead to receiving NGF injections have reported
can be worse the absence of these neurons in affected patients. enhanced responses to pain.7 A treatment based
Chronic pain has a devastating effect on those As they are unable to receive information about on blocking NGF with antibodies has provided
who suffer from it – almost 20% of adults in potentially damaging stimuli and dull pain, they pain relief in animal models and humans,8 but
Europe.1 Commonly used treatments block suffer from repeated trauma to the joints, skin, clinical studies were put on hold due to safety
target molecules involved in the origin or and other tissues. Pain insensitivity disease is rare issues and side effects caused by systemic
maintenance of pain. Probably, there is no ideal but very dangerous. On the bright side, under- application.9
molecule to block all types of pain. Nonsteroidal standing the role of mutations and character- This article reviews a novel approach for pain
anti-inflammatory drugs, opioids, and anti- isation of defective NGF has led to new ideas for treatment that was developed by my colleagues
depressants have limited success in many cases treating chronic pain in other people. What if the at European Molecular Biology Laboratory.10
and cause serious side effects because of systemic source of pain could be eliminated locally at its Mutant NGF protein was used to stop pain at the
delivery.2 Also, from patients’ and doctors’ points origin – by “silencing” or ablating nerve endings periphery by locally photoablating pain-trans-
of view, the adjustment of doses on an individual in the skin? mitting nerves with light-activated photo-
basis can be challenging. sensitisers (Figure 1).
However, no pain can be even worse. For Neuronal growth factor and
example, patients with rare hereditary sensory potential analgesics
and autonomic neuropathy type 5 (HSAN V) NGF has a prominent role in the onset and Light-activated therapy or
report insensitivity to pain and touch.3–5 development of acute and chronic pain states as photoablation for nerves in
Mutations in the neuronal growth factor (NGF) it binds to TrkA receptors. Apart from being the skin
gene, which makes the resulting protein unable important for nerve survival during develop- Light-activated therapy based on cell-targeted
to function properly, are responsible for the lack ment, in the adult nervous system TrkA receptors delivery of photosensitiser IRDye®700Dx
of pain. NGF is essential for the development and are expressed on sensory nerves that transmit (IR700) emerged in 2011 in cancer treatment
survival of neurons that transmit pain, touch, and pain and touch information.6 Volunteers and has been subject to clinical trials.11,12 The

Mutant NGF- Figure 1.

IR700 Scheme for novel pain therapy. Mutant NGF
Near infrared Nerves protein was labelled with photosensitiser IR700
light 690nm withdrawn and injected into the skin of mice with chronic
Skin epidermis nerves
pain. Protein bound to pain-transmitting nerves,
Skin which express TrkA. Near-infrared light
Skin epidermis
illumination activated the photosensitiser
linked to the nerves and led to their
Chronic pain Photoablation Pain relief photoablation. Nerves withdrew, stopping pain
perception.

88 | September 2019 Medical Writing | Volume 28 Number 3

approach relies on the targeted delivery of light- Perspectives monoclonal antibodies. Osteoarthr Cartil.
sensitive IR700 molecules to cells in vivo, thus Results obtained in preclinical studies highlight 2015;23 Suppl 1:S18–21.
sparing all off-target cells, and local near-infrared the promise of photoablation therapy in humans. 10. Nocchi L, Portulano C, Franciosa F, et al.
laser light application to activate the photo- In the quest for more patient-friendly drug Nerve growth factor-mediated photo-
sensitiser. Near-infrared light is harmless to living formulations (to replace injections), effective ablation of nociceptors reduces pain
tissues and penetrates deeper than visible light, delivery of NGF-IR700 via a cream or micro- behavior in mice. Pain. Epub 2019 Jun 26.
thereby allowing light to be applied to deeper emulsion was established. Previously, a cream 11. Mitsunaga M, Ogawa M, Kosaka N,
layers of skin, muscles, or joints. Upon light formulation containing a photosensitiser was Rosenblum LT, Choyke PL, Kobayashi H.
activation, the photosensitiser IR700 releases used to treat a chronic skin itch condition in Cancer cell-selective in vivo near infrared
reactive oxygen species, leading to cell death. mice.15 Therefore, local non-invasive application photoimmunotherapy targeting specific
For pain treatment with light-activated and photoactivation of NGF-IR700 could membrane molecules. Nat Med.
therapy, knowledge about NGF mutations in provide a flexible option for personalised pain 2011;17(12):1685–91.
patients with hereditary sensory and autonomic treatment based on the patient’s sensations of 12. ClinicalTrials.gov [Internet]. Bethesda
neuropathy came in handy. One particular pain and touch in the affected area, with minimal (MD): National Library of Medicine (US).
mutation leads to a defective NGF protein that side effects. Identifier: NCT02422979, Study of RM-
can bind the TrkA receptor but is unable to 1929 and photoimmunotherapy in patients
activate cell signalling, and therefore cannot with recurrent head and neck cancer. 2015
evoke pain by itself.3,7 Engineered mutant NGF References [cited 2019 Aug 10]. Available from
protein was labelled with IR700 and tested on 1. Breivik H, Collett B, Ventafridda V, Cohen https://clinicaltrials.gov/ct2/show/
cells in vitro and in mice in vivo.10 The mutant R, Gallacher D. Survey of chronic pain in NCT02422979.
protein bound to TrkA-positive cells, and after Europe: Prevalence, impact on daily life, 13. Gregory NS, Harris AL, Robinson CR,
exposure to near-infrared laser light, induced cell and treatment. Eur J Pain. 2006; Dougherty PM, Fuchs PN, Sluka KA.
death within 1 day. Mutant NGF-IR700 was 10(4):287–333. An overview of animal models of pain:
injected into the skin of mice and exposed to the 2. Busse JW, Wang L, Kamaleldin M, et al. Disease models and outcome measures.
light. Behavioural signs of pain were measured, Opioids for chronic noncancer pain: J Pain. 2013;14:1255–69.
such as paw withdrawal upon touching with A systematic review and meta-analysis. 14. Deuis JR, Dvorakova LS, Vetter I. Methods
special nylon fibres, a paint brush, or hot/cold JAMA. 2018;320(23):2448–60. used to evaluate pain behaviors in rodents.
stimuli.13 As expected, mice that received mutant 3. Shaikh SS, Nahorski MS, Woods CG. Front Mol Neurosci. 2017;10:284.
NGF-IR700 and light showed no sensitivity to A third HSAN5 mutation disrupts the 15. Nocchi L, Roy N, D’Attilia M, Dhandapani
touch, due to specific local photoablation of pain- nerve growth factor furin cleavage site. R, Maffei M, Traista A, et al. Interleukin-
transmitting nerve endings in the skin. Mol Pain. 2018;14:1744806918809223. 31-mediated photoablation of pruritogenic
4. Carvalho OP, Thornton GK, Hertecant J, epidermal neurons reduces itch-associated
Success of photoablation in Houlden H, Nicholas AK, Cox JJ, et al. behaviours in mice. Nat Biomed Eng.
preclinical pain models A novel NGF mutation clarifies the 2019;3,114–25.
Photoablation technology based on mutant NGF molecular mechanism and extends the
was successful in pain relief in preclinical models, phenotypic spectrum of the HSAN5
where chronic pain arises from tissue injury.10 neuropathy. J Med Genet. 2011;48:131–5.
In different pain models, inactive bacteria were 5. Einarsdottir E, Carlsson A, Minde J,
injected into the skin in a model of inflammation, Toolanen G, Svensson O, Solders G, et al.
a branch of sensory nerves that innervate the skin A mutation in the nerve growth factor beta
was cut in a nerve trauma model, and a toxic gene (NGFB) causes loss of pain
chemical was injected into the knee in a model of perception. Hum Mol Genet.
osteoarthritis and joint pain. After injury, mice 2004;13(8):799-805.
would rapidly withdraw their paws when gently 6. Wood JN. Nerve growth factor and pain.
touched, showing behavioural signs of pain. N.Engl J Med. 2010;363(16):1572–3.
Mutant NGF-IR700 was injected into the injury 7. Petty BG, Cornblath DR, Adornato BT,
site and locally exposed to near-infrared light. Chaudhry V, Flexner C, Wachsman M,
After three consecutive days of treatment the et al. The effect of systemically
mice were behaving normally without signs of administered recombinant human nerve
pain, as before the injury. The effect lasted for at growth factor in healthy human subjects.
least 3 weeks. Authors counted the number of Ann Neurol. 1994;36(2):244–6.
pain-transmitting nerves in skin sections from 8. Cohen SP, Chang D, Hsu E, Hottinger D.
experimental and control mice. After the end of Anti-nerve growth factor in pain
therapy, the nerves had withdrawn from the skin management: current evidence. J Pain Res.
due to photoablation, blocking pain perception. 2016;9:373–83.
However, 1 month after the end of the treatment, 9. Hochberg MC. Serious joint-related Mayya Sundukova
the nerves had grown back, and pain perception adverse events in randomized controlled Rome, Italy
was recovered. trials of anti-nerve growth factor mayya.sundukova@ gmail.com

www.emwa.org Volume 28 Number 3 | Medical Writing September 2019 | 89

Journal Watch Journal Watch is based on the French language blog, Rédaction Médicale et
Scientifique, by Hervé Maisonneuve, available at www.redactionmedicale.fr.

SECTION EDITOR

●
✒ Hervé Maisonneuve
[email protected]

A proposal to define a new category of bad practice – The non-publication of clinical trial results

Poor research practices are usually classified as trust, damages the quality of published research, without reported results should be prohibited from
fraud (fabrication, falsification, and plagiarism) etc. Volunteers who agree to participate in trials applying for additional grants and current grants
and questionable research practices. An editorial believe that their willingness to take risks will be should be suspended. An even stronger incentive
published in Annals of Internal Medicine useful for science. There is no justification for would be to hold institutions accountable for
accompanies a short paper describing the non- hiding trial results. reporting results.2
reporting of clinical trial results, based on 500 The editorial is clear and makes proposals to
trials.1 The survey concluded: “Large trials that consider non-reporting as poor academic References
are unreported for almost 4 or more years after practice, with institutional responsibility: 1. Tatsioni A, Karassa FB, Goodman SN, Zarin
completion are unlikely to be published later or Institutions should suspend investigators who do DA, Fanelli D, Ioannidis JP. Lost evidence
to post results on ClinicalTrials.gov. The loss of not report results within a year of finishing a trial, from registered large long-unpublished
evidence from these trials pertained to almost unless extenuating circumstances exist that impede randomized controlled trials: a survey.
90,000 participants.”2 This is not the first reporting. These institutions also should consider lack Ann Intern Med. 2019 May;171(4):300.
publication to highlight the non-reporting of of reporting in the academic promotion process. 2. Wallach JD, Krumholz HM. Not reporting
clinical trial results. The editorial develops the Funding agencies, such as the NIH, should withhold results of a clinical trial is academic
usual arguments, that non-reporting is contrary support from researchers who do not report results. misconduct. Ann Intern Med. 2019
to the Helsinki Declaration, causes loss of public Investigators who have completed clinical trials May;171(4):293.

Chinese authors overtake US researchers in research publications

The 2018 report of the International research papers globally, with a share of about 19%, References
Association of Scientific, Technical and Medical and on current trends its research spending will also 1. Johnson R, Watkinson A, Mabe M.
Publishers shows that China was ahead of the exceed the US’s by the early 2020s. The US accounts The STM report. An overview of scientific
United States in research publication output.1 for 18% of global articles, while India has also seen and scholarly publishing. International
For 2.3 million English-language articles in rapid growth in recent years, and now produces 5% Association of Scientific, Technical and
peer-reviewed journals: China has overtaken the of global outputs, ahead of Germany, the UK and Medical Publishers. Fifth Edition,
US to become the pre-eminent producer of global Japan, each on 4%. October 2018.

90 | September 2019 Medical Writing | Volume 28 Number 3

A preprint server for healthcare science: medRxiv

The first preprint server was developed by York). BioRxiv is expected to receive approx- and has not been peer-reviewed. It reports new
Cornell University in 1991 in physics: arXiv imately 20,000 preprints per year. There are many medical research that has yet to be evaluated and
(https://arxiv.org/). The system, in which preprint servers, for example those hosted by the so should not be used to guide clinical practice.”
manuscripts are posted online after undergoing Center of Open Science in Charlottesville, Only research articles can be posted; case reports
a minor period of moderation but before peer Virginia (https://osf.io/preprints/). and opinion pieces will not be posted. A key
review by a journal, is a success. As of July 2019, In medicine, projects have been announced
screening question will be whether a preprint, if
arXiv has more than 1.5 million e-prints in the since 2017, but many controversies exist. Some
posted, has the potential to do harm to individual
fields of physics, mathematics, computer science, journal editors are opposed to the practice of
patients or the public. If in doubt, medRxiv will
quantitative biology, quantitative finance, submitting manuscripts before peer review. The
not post the preprint; the authors will be
statistics, electrical engineering and systems creation of medRxiv was announced in June
science, and economics. It was only later (2013) 2019, and it is possible to submit preprints at encouraged instead to publish only after peer
that a preprint server was created in biology/life https://www.medrxiv.org/. MedRxiv is managed review.
sciences, and after a slow start, it is considered a by three partners: Cold Spring Harbor Labora- Will the presence of the BMJ in this project
success. BioRxiv (https://www.biorxiv.org/) is tory, the BMJ, and Yale University. A warning influence the behaviour of researchers and other
run by Cold Spring Harbor Laboratory (New appears for each paper: “This article is a preprint medical journal editors?

Is the future of mega-journals as a major publishing platform threatened?

The arrival of mega-journals in the early 2000s We show that nonselective megajournals have
has been acclaimed by the scientific community. started to decline in all bibliometric parameters.
These journals were open access and all research These journals in particular have lost connection
results became accessible. The model was to with the most advanced science as revealed by the
publish any research, provided that the methods decreasing citations to and from the top-tier journals.
were sound. The acceptance rate is around 60% While some megajournals have underperformed on
to 70%. These mega-journals published all types bibliometric parameters from the beginning of their
of research and were not restricted to limited existence, others experienced a short honeymoon
areas. An academic editor is appointed for each period before declining. In contrast, major discipline-
paper submitted and is responsible for the peer specific open-access journals remain competitive, and
review process. Review notices are often posted those published by less prominent publishers have
online with the article. There is no large editorial even increased their performance. However, the
board like the journals of learned societies. Some articles in the years 2013–2015. Competitors discipline specific open-access journals also display
thought that 100 mega-journals would be enough then appeared, including Springer’s Scientific decreasing citations to and from the top-tier journals.
to publish all the science. The economic model Reports. The annual number of articles published The old model of learned society journals, of
consists in charging authors publication fees then declined slightly, as did the impact factor the prestigious journals of major publishers is not
when the article is accepted for publication, after (from about 4 to 3). dead. The future of scientific journals still holds
peer review. The fee, known as an article Petr Heneberg analysed the bibliometric surprises for us.
processing charge, varies according to the journal, parameters of 11 megajournals and compared
often in the range of $1000 to $4000. them with three control groups of gold open- References
The first mega-journal was PLOS ONE, access journals that do not satisfy the criteria for 1. Heneberg P. The troubles of high-profile
created in 2006 by the Stanford University megajournals and that do not apply the concept open access megajournals. Scientometrics.
Library, and it published approximately 30,000 of “sound science”.1 2019;120(2):733–6.

www.emwa.org Volume 28 Number 3 | Medical Writing September 2019 | 91

Good Writing Practice
Syntactic number distraction
Circumlocution: Pre- or post-noun modification

SECTION EDITORS

●
✒
Wendy Kingdom
[email protected]

●
✒
Amy Whereat
[email protected]

Part 2 – Materials and

methods section: Materials
Example: excessive post-noun modification
The sample from the University of North
Carolina two-phase randomised clinical trial
comprised preadolescent children with increased
overjet (>7 mm), in mixed dentition, a year
before peak pubertal growth, and without
previous orthodontic treatment.

Revision
The sample was from the University of North
Carolina two-phase randomised clinical trial.
The inclusion criteria were (1) preadolescent
children a year before peak pubertal growth,
(2) increased overjet (>7 mm), (3) no previous
orthodontic treatment.

Notes
In the Example, a series of four prepositional
phrases conveying primary information is
Introduction Revision torturous to comprehend in contrast to a
Excessive post-noun modification, usually as Cells were washed twice with 1 x PBS and numerical listing of noun phrases in the Revision.
adjectival prepositional phrases, occurs fre- isolated by centrifugation (6 min, 1600 rpm). The enumerated listing facilitates compre-
quently in research writing. Occurring less hension, a facilitation that is further enhanced by
frequently, and less distracting, is excessive pre- Notes combining related criteria. Furthermore, such
noun adjectival modification (i.e., stacked The tandem post-noun prepositional phrases are information insight enables in mixed dentition to
modification). The post-noun adjectival mod- details of centrifugation. Such secondary level be self-evident for children of that age.
ification often occurs after a noun functioning as information can be demarcated from primary by
an object of an adverbial prepositional phrase. using parenthesised noun phrases. Even the Part 3 – Results section:
details of washing could also be so reduced to the Data-based observation
Experimental sections noun phrase (1 x PBS). Example: unnecessary post-noun modification
In the Revision, minutes can be abbreviated to Skeletal muscle hypertrophy was accompanied
Part 1 – Materials and methods min, which lacks plurality and punctuation. by an acceleration of protein synthesis and an
section: Method Furthermore, deletion seems to prompt deletion; increase of A1B uptake.
Example: excessive post-noun modification that is, with the deletion of the prepositions and
Cells were washed twice with 1 x PBS and abbreviation of the units, isolated by centrifugation Revision 1
isolated by centrifugation for 6 minutes at seems a circumlocution of simply centrifuged. The Skeletal muscle hypertrophy was accompanied
1600 rpm. verbs in the sentence are now parallel: were by accelerated protein synthesis and increased
washed …and centrifuged. A1B uptake.

92 | September 2019 Medical Writing | Volume 28 Number 3

Revision 2 compartment heterogeneity result in an A-P the preposition to is redundant with the infinitive
Skeletal muscle hypertrophy was accompanied by symmetry within the feather buds: posterior marker to, which is resolved by transposition of the
increased protein synthesis and A1B uptake. expression (Notch, Serrate, and Wn7a) and infinitive phrase to the sentence start position.
anterior expression (BMP-4 and Tenascin).
Notes Part 4 – Introduction section:
In the two sets of tandem prepositional phrases, Notes Objective + experimental
not only do the nouns acceleration and increase add The examples of posterior and anterior expression approach
to noun density and abstraction, but their are secondary information, which can be Example: excessive pre-noun modification
presence each necessitates a contiguous prepo- syntactically reduced from prepositional phrases Angiopoietin regulation of choroidal endothelial
sition: (acceleration of; increase of). Revision 1 into parenthesised noun phrases. cell MM-P and MM-9 activities was investigated
involves syntactic reduction of a prepositional by gelatin zymography.
phrase into the adjectival past participles Part 2 – Introduction section:
accelerated and increased. In Revision 2, with the Research problem pertinent Revision
deletion of the preposition and the article, the background Angiopoietin regulation of MM-P and MM-9
subtle distinction between accelerated and Example: excessive post-noun modification activities in choroidal endothelial cells was
increased becomes unintended. During tooth morphogenesis, Syndecan-1 investigated by gelatin zymography.
expression is essential for the condensation of
Part 4 – Results section: dental mesenchyme. Notes
Data-based observation There are five pre-modifiers before activities that
Example: excessive pre-noun modification Revision 1 impede comprehension. Transposition of
Extremely low birth weight infants were the During tooth morphogenesis, Syndecan-1 express- choroidal endothelial cells into a post-noun position
primary occupants of the neonatal critical care ion is essential for dental mesenchyme separates the type of activities from their location
unit. condensation. and provides a balance between the number of
pre- and post-modifiers, a balance that enhances
Revision Notes comprehension.
Extremely low-birth-weight infants were the In the Example the two contiguous post-noun
primary occupants of the neonatal critical care prepositional phrases can be syntactically melded. Summary
unit. The Revision is accomplished by transposition of The distribution of the two examples of excess pre-
the object dental mesenchyme of the second noun modifiers and the six examples of post-noun
Notes prepositional phrase into a pre-noun modifier modifiers is equal between Experimental sections
Three coordinated adjectival pre-modifiers will be (dental mesenchyme) of the object of the first (Results) and Contextual sections (Introduction).
mildly distracting to an expert in the discipline, prepositional phrase. Thus, melding reduces the The rhetorical severity of these examples is
but more so for a non-expert. In the Revision, tandem prepositional phrases into one. dissonance and possibly impeded comprehension.
virtual unstacking is accomplished by hyphen- Revision of excess pre-modifiers can range from
ation, which unites the three modifiers so that they Part 3 – Introduction section: hyphenation (whereby the pre-noun modifiers are
function as one unit. Low is an adjective, but birth Research problem pertinent visually transformed into one unit) to transpo-
and weight are nouns functioning adjectivally. background sition (whereby a pre-modifier is transposed to a
Thus, the three pre-modifiers are adjectival in Example: excessive post-noun modification post-modifier). In contrast, revision of post-
function. The fourth modifier extremely, probably Orthopaedic surgeons are setting arbitrary modifiers involves a variety of syntactic options:
a cumulative modifier (i.e., modifies low-birth- restrictions on the return to activities, with the melding of tandem appositives; parenthesis or
weight), as most -ly adverbs, is usually not intent of protecting the graft from injury. listing (both of which involve syntactic reduction
hyphenated. of a prepositional phrase into a noun phrase), or
Revision 1 conversion into another syntactic unit (e.g.,
Contextual sections Orthopaedic surgeons are setting arbitrary infinitive phrase).
restrictions on the return to activities to protect
Part 1 – Introduction section: the graft from injury.
Research problem pertinent
background Revision 2
To protect the graft from injury, orthopaedic
Example: excessive post-noun modification surgeons are setting arbitrary restrictions on the
The inter-compartment heterogeneity, such as return to activities.
posterior expression of Notch, Serrate, and
Wnt 7a, and anterior expression of BMP-4 Notes
and Tenascin, results in an A-P The tandem prepositional phrases Michael Lewis Schneir, PhD
asymmetry within the feather buds. with the intent of protecting is Professor, Biomedical Sciences
narrative and wordy. In Revision 1, Ostrow School of Dentistry of University
Revision the infinitive phrase to protect can be of Southern California, Los Angeles, CA
The following examples of inter- used to convey intent. Repetition of [email protected]

www.emwa.org Volume 28 Number 3 | Medical Writing September 2019 | 93

Regulatory Public Disclosure
Editorial (CSRs) and clinical summary documents that we SECTION EDITOR
In the world of regulatory public disclosure have to date seen from the EMA and Health
(RPD) things rarely stay the same for long. This
regular RPD section in Medical Writing and
Canada. (See Status updates from regulatory
regions box for links.) ●
✒ Sam Hamilton
[email protected]

EMWA’s RPD SIG help you keep up. EMA continues to hold clinical data
On June 26, 2019, the FDA concluded the publication activities. An EMA Management summary results posting (Clinical trial
recruitment phase of its clinical data summary Board meeting is planned in October 2019 to disclosure: Perspective from a medical writer
pilot programme in which one sponsoring review the situation, but as these activities are not for a contract research organisation, p. 52).
pharmaceutical company voluntarily particip- listed as 2019 priorities, I expect that there will Clarity and Openness in Reporting: E3-
ated. The FDA published a Federal Register be little, if any, movement. based (CORE) Reference, developed by the
notice (Docket No. FDA-2019-N-2012) On a more positive note, EMA’s improved Budapest Working Group (BWG), a
seeking feedback on the pilot, the comment methodology for the IT system – the Clinical partnership of AMWA and EMWA, is a user
period for which closed on August 26, 2019. Trials Information System (CTIS) – that will manual designed to help medical writers
The FDA solicited feedback through a series of enable the EU’s Clinical Trial Regulation to come navigate relevant guidelines as they create
stakeholder questions designed to gather into force, will hopefully lead to improved clinical study report (CSR) content. CORE
insight into potential benefits or risks, resource delivery. Member states and stakeholders Reference was one of two principal sources
requirements, and challenges of the FDA (including business experts) are now directly used by TransCelerate BioPharma Inc., an
publicly releasing a limited number of sections engaged in the development of CTIS to ensure alliance of biopharma companies, in the
from certain CSRs at the time of marketing that their expectations are taken into account. development of its CSR Template released in
approval. The FDA also released a new This means that business expert representatives November 2018. A new CORE Reference open
integrated template that will be used to may continuously review, select, and verify CTIS access article, was published in August 2019 in
document the FDA’s review of new drug functionalities (See Status updates from the the BioMed Central journal, Research Integrity
applications and efficacy supplements. The regulatory regions box for links) and Peer Review.
same Federal Register notice sought public This issue’s RPD feature article comes from The publication is available at https://
comment on the new integrated template. Art Vivien Fagan. Viv tells us about her transition doi.org/10.1186/s41073-019-0075-5. Key
Gertel (CORE Reference Strategist) and I sub- from the field of dedicated regulatory medical resources from this publication are posted on
mitted our comments in July 2019. This writing into the world of clinical trials disclosure the CORE Reference website and are directly
important development is of interest to our within a global clinical research organisation accessible via the links in the box below. To
professional community because this opens a environment and how she melds the two to whet your appetite, we also reproduce here,
potentially new and alternative pathway for ensure disclosure-readiness from the outset. Viv’s with permission, the abstract from the original
public disclosure of clinical information to that article includes some great tips on gaining Research Integrity and Peer Review article.
of the publication of clinical study reports efficiencies from results reporting through to Kind regards, Sam

94 | September 2019 Medical Writing | Volume 28 Number 3

Abstract from:
Critical Review of the TransCelerate Template for Clinical Study
Reports (CSRs) and Publication of Version 2 of the CORE Reference
(Clarity and Openness in Reporting: E3-based) Terminology Table
Hamilton S, Bernstein AB, Blakey G, Fagan V, Farrow T, Jordan D, Seiler W, Gertel A. on behalf of the Budapest Working Group

Background and recommendations in this communication. important milestone in authoring CSRs, we offer
CORE (Clarity and Openness in Reporting: E3- We also re-examined and edited the Version 1 CSR authors advice and recommendations on its
based) Reference (released May 2016 by the CORE Reference Terminology Table that we first use, similarities, and differences with CORE
European Medical Writers Association [EMWA] published in 2016, and we present this as Version Reference and advise them to consider shared
and the American Medical Writers Association 2 in this communication. interpretations between the two.
[AMWA]) is a complete and authoritative open-
access user’s guide to support the authoring of Results Registration
clinical study reports (CSRs) for current Our major critical review findings indicate that CORE Reference is registered with the
industry-standard-design interventional studies. opportunities remain to refine the CSR template EQUATOR Network. The TransCelerate CSR
CORE Reference is a content guidance resource structure and instructional text, enhance content template is not registered with any external
and is not a CSR template. clarity, add web links to referenced guidance organisation to the knowledge of the authors of
TransCelerate Biopharma Inc., an alliance of documents, improve transparency to support the this paper.
biopharmaceutical companies, released a CSR broad readership of CSRs, and develop support-
template in November 2018 and recognised ing resources. Critical Review of the TransCelerate Template
CORE Reference as one of two principal sources The CORE Reference “Terminology Table” for Clinical Study Reports (CSRs) and Publi-
used in its development. Version 2 includes estimand as a defined term cation of Version 2 of the CORE Reference
and an adaptation of the original ‘worked study (Clarity and Openness in Reporting: E3-based)
Methods example’ to incorporate the recently evolved Terminology Table: http://dx.doi.org/10.1186/
The regulatory medical writing and statistical concept of “estimands”. s41073-019-0075-5
professionals who developed CORE Reference
conducted a critical review of the TransCelerate Conclusions Reproduced under the terms of The Creative
CSR template. We summarise our major findings As TransCelerate’s CSR template represents an Commons Attribution License 4.0

Status updates – from regulatory regions

Europe lot of information in the Q&A, as we might (https://www.ema.europa.eu/en/ human-

1. Priority goals for EMA in 2019 (https:// expect – do note Section 6 “Submission of regulatory/research-development/clinical-
www.ema.europa.eu/en/documents/work- Clinical Trial Results” (https://ec.europa. trials-human-medicines).
programme/ema-activities-other-highest- euhealth/sites/health/files/files/eudralex/vol-
priority-activities-category-1-activities-will-con 10/regulation 5362014_qa_en.pdf). United Kingdom
tinue-2019-annex-1_en.pdf); EMA guideline 4. Reporting of clinical trial results in EudraCT 5. Further detailed guidance published Sept
development and clinical trial data publication is the direct responsibility of sponsors. The 2019 (https://www.gov.uk/government/
on hold (https://www.ema. europa.eu/en/ EMA and the Heads of Medicines Agencies publications/further-guidance-note-on-the-
about-us/united-kingdoms-withdrawal- have issued a joint letter to remind sponsors regulation-of-medicines-medical-devices-
european-union-brexit). of their responsibilities. They particularly and-clinical-trials-if-theres-no-brexit-deal)
2. CTIS project methodology updated in June 2019 mention underreporting by non-commercial includes a major update on all aspects of
to engage stakeholder input: https://www.ema. sponsors and provide links to resources that medicines and devices regulation in the UK
europa.eu/en/human-regulatory/research- all stakeholders may find useful in meeting in the event of a no-deal Brexit. See Section 3
development/clinical-trials/clinical-trial- their reporting obligations. This July 3, 2019, “Clinical trials of Investigational Medicinal
regulation. joint letter (https://www.ema.europa.eu/en/ Products” for details relevant to the clinical
3. EU guidance documents applying to clinical documents/other/joint-letter-european- trials community.
trials are described in the Clinical Trials commi ssion-ema-hma- stakeholders - Register here to make MHRA submissions:
Regulation (EU No. 536/2014). A draft Q & A regarding-requirements-provide-results_en.p https://www.gov.uk/guidance/making-
document dated June 2019 has been released df) and this press release (https://www.ema. submissions-to-the-mhra-in-a-no-deal-
and submitted for discussion to the Expert europa.eu/en/news/call-all-sponsors- scenario?utm_source=8f1e190e-4364-43e3
Group on Clinical Trials. Some sections of the publish-clinical-trial-results-eu-database? -b35a-4201a261b4c6&utm _ medium=
Q&A are incomplete and we can therefore mkt_tok=ey) are posted on the EMA’s email&utm_campaign=govuk-notifications
expect this document to be updated. There is a Clinical Trials in Human Medicines page &utm_content=daily

www.emwa.org Volume 28 Number 3 | Medical Writing September 2019 | 95

United States LBCTR is also becoming a data provider and (2019) (https://researchintegrityjournal.
6. The FDA concluded the recruitment phase trials registered with LBCTR will be added biomedcentral.com/articles/10.1186/s4107
of its clinical data summary pilot programme to the ICTRP database. LBCTR was 3-019-0073-7) describes the relationship
(https://www.fda.gov/drugs/development- established by the Lebanese Ministry of between professional medical writing supp-
approval-process-drugs/clinical-data- Public Health with the support of the WHO ort for authoring CSRs, and the quality,
summary-pilot-program) and published a Lebanon office and the WHO Eastern ethics and timeliness of publications
Federal Register notice seeking feedback on Mediteranean Regional Office (EMRO) IT reporting clinical trials.
the pilot and a new integrated template team. This new registry will contribute to 10. Clinical trial registry reporting: a transparent
( h tt p s : / / w w w. f e d e r a l r e g i s t e r. g o v / research transparency in the EMRO region solution needed (https://doi.org/10.1016/
documents/2019/06/27/2019-13751/new- and will ensure the registration of all clinical S1470-2045(19)30350-X) is a Lancet
drugs-regulatory-program-modernization- trials conducted in Lebanon (https:// editorial that highlights the shortfall in trial
improving-approval-package-documentation www.who.int/ictrp/news/en/). registry results reporting by universities in
-and). The applicable Docket No. FDA-2019- Europe. University triallists are encouraged to
N-2012 for “New Drugs Regulatory Program … from the journals take the lead and make the necessary uploads,
Modernisation: Improving Approval Package 8. Miller J, et al. Sharing of clinical trial data and and it is suggested that clinical trial registries
Documentation and Communication”, results reporting practices among large could send out automated email reminders.
including the background documents and pharmaceutical companies: cross sectional 11. Rocher L, et al. Estimating the success of re-
comments received, is at: https://www. descriptive study and pilot of a tool to improve identifications in incomplete datasets using
regulations.gov. Just insert the docket company practices. BMJ 2019; 366:l4127 generative models. Nature Communications,
number into the search box and follow the (http://dx.doi.org/10.1136/bmj.l4127) shows 2019; 10 (1) (https://www.nature.com/
prompts. Comments from Sam Hamilton that “…Despite noteworthy commitments by articles/s41467-019-10933-3) shows that
and Art Gertel are also available at some companies to share participant level trial allowing data to be used, to train artificial
https://www.core-reference.org/media/ data and a willingness by others to improve intelligence algorithms, for example is risk
1053/docket-fda-2019-n-2012_answers-to- their policies, many companies still have laden. This new research shows that once
fda-qs_sh-and-ag_150719.pdf. substantial room for improvement.” bought, the data can often be reverse engi-
9. Evuarherhe O, et al. Professional medical neered using machine learning to re-identify
Eastern Mediterranean writing support and the quality, ethics and individuals, despite the anonymisation
7. On July 25, 2019, the Lebanese Clinical timeliness of clinical trial reporting: a techniques.
Trials Registry (LBCTR) became a member systematic review. Research Integrity and
of the Primary Registry Network of ICTRP. Peer Review volume 4, Article number: 14

CORE Reference Resources 2. The Center for Biomedical Research Trans-

l Hamilton S, Bernstein AB, Blakey B, et 1. The EMA’s Scientific Advice Working Party parency aims to increase transparency in
al. Critical Review of the TransCelerate released “Draft qualification opinion of biomedical research reporting. This ISMPP
Template for Clinical Study Reports clinically interpretable treatment effect Newsletter reports the content that was
(CSRs) and Publication of Version 2 of measures based on recurrent event endpoints presented in a free-to-attend meeting in the
the CORE Reference (Clarity and that allow for efficient statistical analyses” – EU in May 2019 (https://ismpp-newsletter.
Openness in Reporting: E3-based) which is relevant for development of com/2019/06/18/ introducing- cbmrt-its-
Terminology Table. Research Integrity estimands, i.e., clinically interpretable transparency-initiatives-and-ambassador-
and Peer Review. https://doi.org/ treatment effect measures (https://www. network/). More of these meetings are
10.1186/s41073-019-0075-5. ema. europa.eu/en/documents/scientific- planned for the EU and US. Although the
l CORE Reference (available for guideline/draft-qualification-opinion- topics of interest relate predominantly to
download from http://www.core- clinically-interpretable-treatment-effect-mea publications transparency, (and less so to
reference.org/core-reference/) sures-based-recurrent-event_en.pdf ). clinical data transparency in the clinical
identifies each point in an ICH E3- Development of medicines is becoming trials industry), free meetings like this
compliant CSR where anonymisation increasingly estimand-based, and as we all where there is overlap of these areas may be
considerations should apply. try to better understand this developing of interest.
Downloads stand at 22,500+ (Sept field, I urge you share this opinion with your 3. EMWA RPD SIG members’ page: https://
2019) statistical colleagues. See Table 2 at www.emwa.org/members/special-interest-
l CORE Reference News Summaries: https://researchintegrityjournal.biomedcen groups/regulatory-public-disclosure-sig/
https://www.core-reference.org/news- tral.com/articles/10.1186/s41073-019- Subpage for disclosure-related regulatory
summaries and “real time” updates: 0075-5/tables/2 for incorporation of news updates: https://www.emwa.org/
http://www.core- estimand into the original CORE Reference members/spec ial-interest- groups/
reference.org/ Terminology Table worked example regulatory-public- disclosure-sigregulatory-
subscribe news-emwa-newsblast/.

96 | September 2019 Medical Writing | Volume 28 Number 3

 SECTION EDITORS

Out on Our Own ●

✒
Laura A. Kehoe
[email protected]

Welcome readers, course is not limited to freelancers, but as he complete and then step into the career path.
It is a pleasure for me to share an article in this points out, many volunteers within the organ- We all have varied backgrounds and are from
issue from our previous Out on Our Own isation are indeed freelancers. He offers a great different countries, and often have fallen into
(OOOO) section editor, Satyen Shenoy. For overview of the structure of EMWA and how it medical writing. I love hearing the paths that
those that don’t know him, where have you is run and where volunteers are needed. Get other freelancers have taken and always along
been? Satyen, as he will describe, has been on involved! the way we have gained experiences that can be
the EMWA scene for many years. In Vienna, Also in Vienna, I spoke to two enthusiastic vital to share with others who are contempl-
Satyen hung up his Freelance Business Group attendees of the Freelance Business Forum, ating the freelance direction. Diana and Matías
chairperson hat and placed it on my head. He Diana Ribeiro and Matías Rey-Carrizo, who were both offer us their journey and how they ended
went into a period of contemplation and asked experiencing it for the first time. When I up in the Freelance Business Forum. Many
to contribute to this OOOO issue. Over the approached them after the congress their thanks to all our authors for sharing their views
years, one question kept cropping up and enthusiasm was still high, and they both agreed and advice.
continues to, how to volunteer for EMWA? He to write articles on their personal journeys into Happy reading!
summarises the volunteering opportunities freelancing. As I mention to many people,
throughout the EMWA organisation, this of medical writing is not a degree that one can Laura A. Kehoe

Growing as a freelancer through volunteering

In my three-and-a-half years as a volunteer for serving on the Executive Committee (EC) or as want to make is that freelancers are actively
EMWA’s Freelance Business Group (FBG), table leaders at the FBF, we are all volunteers. involved in the running of EMWA.
I have had the opportunity at our biannual Freelancers get involved by being EMWA In recent years, numerous programmes such
conferences to meet and network with many Presidents (as with the current president, Barbara as the symposium and expert seminar series at
EMWA members, most of them freelancers. Grossman) and EC members, and also serve on the summer conferences have been initiated and
What has encouraged me particularly has been various subcommittees and special interest these require assistance and inputs. In addition,
the increasing number of new faces I see groups (SIGs). The five volunteers on the FBG various SIGs – medical communications,
attending the Freelance Business Forum (FBF); subcommittee are all freelancers. The point I veterinary, medical devices, etc., have been
this indicates that freelancing is fast becoming an launched, all of which requires active volunteers.
attractive option for medical writers. One of the So, how does one go about finding these
questions that I have received from freelancers opportunities to volunteer? Well, you could read
over and over again, in person and by email is – about them on the EMWA website or in the
“how can I volunteer for EMWA?” Now, since I monthly Newsblast in your email inbox or by
pretty much serendipitously got involved with checking EMWA’s social media portals. You
EMWA after being invited to help the FBG as a could also drop a line to our head office
freelance advocate, I have often crafted an ([email protected]) and they will connect you
impromptu and patchy reply, not entirely to with subcommittee/SIG chairs.
my satisfaction. So, in this article I would like
to answer this question comprehensively and Workshop leaders
list different volunteering opportunities as a One of EMWA’s most sought-after programmes
guide for those freelancers who are interested in is the EMWA Professional Development
volunteering for our organisation. Programme (EPDP), which organises workshops
at EMWA conferences. With over 120 different
Executive Committee, workshops that cover a range of subjects, the
subcommittees, and special EPDP provides quality training to medical
interest groups writers and helps them develop new skills. The
EMWA activities are exclusively managed by EPDP is also a perfect opportunity for freelancers
volunteers, of course, with an efficient adminis- Satyen Shenoy handing over the with a passion for teaching, such as myself, to
trative support from our office staff in chairpersonship to Laura A. Kehoe at the volunteer as workshop leaders. The process is
Macclesfeld, UK. Whether it be members Vienna EMWA congress. well-regulated, in that potential workshop leaders

www.emwa.org Volume 28 Number 3 | Medical Writing September 2019 | 97

need to send in a proposal to the EPD Webinars programme (OOOO) section which is dedicated to
Committee (EPDC) for a workshop, which is For the past couple of years EMWA’s Webinar freelancing issues. Recently, a new online feature
then evaluated for suitability and other factors. Programme has been hosting monthly webinars called “Web Editorial”, which publishes opinion
Once approved and refined, the workshop is then on a variety of topics relevant to the medical pieces on relevant topics, has also been added to
offered at future conferences. It was a fabulous writing profession – from latest regulatory the EMWA website. During my tenure as the
experience when an EMWA colleague and I changes to improving writing skills. Besides being editor of OOOO, I have had the privilege to
underwent the process and developed a useful a good source of information and tips for EMWA bring to print a number of articles from
workshop which was first offered at the autumn members, this programme also allows presenters freelancers offering tips and tricks, their opinions
conference last year in Warsaw. And from a to share their particular expertise with their and perspectives on business management, etc.
personal viewpoint, it felt good to be able to share fellow medical writers. So, if you wish to present To give you an idea on how valuable these articles
with the workshop attendees the knowledge I a webinar on a topic that you are proficient in are, I would like to share an anecdote. When I
have gained in my career as a scientist and a then you could contact the volunteers, Laura decided to launch my freelance consultancy in
medical writer. So, if you wish to design and Collada Ali or Carolina Rojido, who oversee the Germany, I had no idea where to start. One of the
present a workshop at EMWA conferences, do programme and discuss it with them. senior EMWA members, whom I had met at a
get in touch with the Chair of the EPDC, Marion conference, advised me to look into the OOOO
Hodges. Local networking archives in the Freelance Resource Centre on the
While EMWA conferences are a fantastic EMWA website. I did so and found two articles
EMWA Ambassador opportunity to expand one’s networks and get to by another freelancer based in Germany who had
Programme know other freelancers, it is not always practical gone through the hoops a few years earlier and I
The EMWA Ambassador Programme is another for freelancers to attend all of these. To address found these to be immensely informative. Since
recent initiative launched to raise general this, freelancers around Europe have taken to then, I have been actively requesting freelancers
awareness of medical writing as a profession; as local networking and organising informal get- to volunteer to write articles for the OOOO. Your
well as to introduce EMWA to those finishing togethers. While this is rather well-established in stories and experiences, your observations and
their education, and looking for career options. the UK, at present local networking is gaining pointers; these could be helpful to your fellow
Towards this, volunteers in the Ambassador ground in the Netherlands, France, and Germany. freelancers. And if you wish to share these with
Programme visit university career events, medical The advantages for participating in these are us then do contact the Editor-in-Chief of Medical
conferences, medical communication events, numerous. From getting a sense of camaraderie, Writing, Phil Leventhal, the Editor of OOOO,
etc., and make presentations on medical writing to shooting the breeze with fellow professionals, Laura A. Kehoe, or our Website Manager,
on how a EMWA membership helps one develop to catching up on and discussing latest develop- Diarmuid De Faoite.
as a medical writer. Since one of my goals as a ments in our field; freelancers tend to benefit
freelance medical writer is to help develop the from such interactions. Such events are also Conference participation
medical writing profession in Germany, I signed useful for introducing non-members to EMWA Since we freelancers are primarily business
up as a volunteer at the last EMWA conference and its activities. So how could you volunteer? owners, network development is the key to our
in Vienna. Besides joining the programme to Look for other medical writers in your area, get success. EMWA conferences are a great venue to
canvas EMWA’s outreach, there’s another way of connected, and start forming a network. And yes, engage in networking with other freelancers and
volunteering to help the programme. And that is do talk about EMWA to non-members. non-freelancers, some of whom will also be
through gathering information in your area on volunteers. From these, you will get to hear about
career events, job fairs, and passing on the Writing for Medical Writing new initiatives and opportunities to help out, and
information to the Chair of the Ambassador or the website you could volunteer your thoughts and ideas. It
Programme, Abe Shevack. In addition, if you EMWA’s journal, Medical Writing, has developed is a classic feed forward process where, with each
have contacts at universities and research in leaps and bounds in the past few years with conference you attend, your network grows and
institutes, it would be worthwhile exploring the contemporary and relevant themes, feature you will have more opportunities to share your
possibility for the nearest volunteer with the articles that are open access, an extended content, opinions and perhaps even be invited to join a
programme to make a presentation to the post- and getting listed in indices such as Scopus, committee or propose a new workshop.
graduate students at these places. EBSCO, and Google Scholar. Besides this, it still While I may have serendipitously been
continues to have the Out On Our Own offered an opportunity to be an EMWA
volunteer, it is an experience that does give me
immense satisfaction. Like most wannabe
Future issues: volunteers, I too felt unsure at the start,
We are always looking for people to contribute to the future issues of the OOOO. Here, are a few wondering if I would ever be able to make time
themes that we’d like to address, so if you have something to say and want to contribute please get in or contribute my best efforts for the FBG and
touch. EMWA as a whole. But with some fantastic
1. From freelancer to business entrepreneur support and encouragement, I did give my time
2. Which path to take, MedComms or regulatory? How? And what’s the difference? and my best. At present, as a workshop leader and
3. “Experienced” vs “non-experienced” freelancers: stepping into freelancing too early? a volunteer on the ESS committee and the
If you have any additional topics that you’d like to see in our section, then we are always happy to Ambassador Programme, I do feel like I have
hear. given something to an organisation that has given
me so much, most important of which is an

98 | September 2019 Medical Writing | Volume 28 Number 3

identity as a professional medical writer. who I first met when she gamely volunteered to Happy volunteering!
In Vienna, I resigned from the FBG be a table leader at the FBF at the autumn
subcommittee to make way for another eager conference in Cascais in 2017. I must add that it Satyen Shenoy
volunteer to join and have the opportunity to was her first FBF. And that is the best part about Describe Scientific Writing &
contribute. In Vienna, I also handed over the EMWA – new volunteers always step up to the Communications
chairpersonship of the FBG to Laura A. Kehoe, plate, bringing with them fresh ideas and a desire
a fellow EMWA member and a dear colleague to help our organisation grow. And grow we shall.

Getting into medical writing through the Freelance Business Forum

There is nothing like looking, if you want to find questions (namely: what is a medical writer?), drinks and snacks, and I learned useful tips
something. You certainly usually find something, she directed me to the EMWA website. I looked about medical writing and freelancing. I also
if you look, but it is not always quite the around the website, searching for some kind of discovered that medical writers are very
something you were after. information that allowed me to feel comfortable resourceful: they can host a round table
J.R.R. Tolkien, The Hobbit in saying that I had the ‘right’ profile to be a discussion without a table of any kind! There
medical writer. were not enough tables, and Carolina Rojido
Not having the usual academia or industry I never found that magical piece of was left tableless for her discussion, but she did
background made me question if I could throw confirmation, but I did find a webinar open to not let that get in her way. It’s all about people,
myself into the freelance medical writing world non-members. There, Satyen Shenoy explained ideas, and having a great conversation, after all.
and be successful. Attending the Freelance the benefits of EMWA for freelancers. That
Business Forum (FBF) in Vienna gave me swayed me into becoming an EMWA member Sharing, learning, and having
confidence and a clearer vision for what I want and gave me confidence to acknowledge that fun
my journey to be. with enough planning and hard work I could Time flew during these discussions, and I am
build a new career as a freelance medical writer. only sorry that I did not take part in more of
From over-the-counter to them. I would also like the tables to have been
writing Next stop: Vienna, Freelance a bit bigger. With so many of us attending the
My journey to become a medical writer is a Business Forum forum, there was a kind of a bullseye forming
recent one. For over 10 years I worked in One thing that came up again and again in the around each table, making the ones in the outer
healthcare, first as a pharmacy technician and OOOO articles of Medical Writing journal was circles having to strain to hear the discussion
later as a pharmacist. In both roles I kept the benefits of attending the FBF. Everyone and making it harder to participate in it.
longing for some other aspect of communi- wrote about how great it was to get to know The air was thrumming with energy. I talked
cation than the simple-yet-complicated fellow freelancers – it was like having a tribe with many like-minded people, all in great
interaction with patients at the pharmacy inside the medical writing community. So, when spirits, keen to support each other in their
counter. Besides talking to people, I enjoyed I signed up to the Vienna conference, it was a no- freelance journeys.
writing information handouts and drug brainer to sign up to the FBF too. I even got to talk with Satyen, but before I
interaction reports for patients. I was also I was looking forward to attending the could thank him for putting up the webinar that
known for being always busy researching roundtable discussions, going from table to table ultimately brought me to EMWA, pride got in
something and studying new (and old) like a bee in a meadow, hearing what everyone the way. You know, I am from Cascais, where a
medications. Over time, I realised that I would had to say. previous EMWA conference was held and
like to do more work in writing and com- In Vienna, after an opening speech by Satyen praised by Satyen in his opening speech. And
munication, and less in retail pharmacy. and a short presentation from a fellow this made my proud inner geek deliver a crash
In early 2018, I connected with Maria João experienced freelancer, the tables were set up. course on pronunciation… Satyen was graceful
Almeida on LinkedIn. She is a Portuguese The table leaders moderated the discussion of enough to pronounce “kesh-kay-shh” to my
medical writer and a member of EMWA’s their assigned table, giving prompts and keeping satisfaction, but I am fully expecting some kind
Executive Committee. After answering my the conversation going. It was a happy affair, with of revenge on an forthcoming event.
In the end, I left the FBF thankful for all the
networking and learning. I would like it to be
longer. I would like it to have more information.
More discussion, more sharing.
In a nutshell, I want more FBF.

Diana Ribeiro
Apothecary Medical Writing,
Portugal
[email protected]

www.emwa.org Volume 28 Number 3 | Medical Writing September 2019 | 99

Networking: The important part of the Freelance Business Forum
I would like to share with you my thoughts and accomplished medical/scientific writer at my I went back home with some nice tips and a
impressions on the Freelance Business Forum second EMWA Conference in Vienna on May broader vision of subjects affecting medical
(FBF), in case it may be of any interest to other 2019. I signed up for the FBF without knowing writing I could not have thought of myself.
freelance rookies. But first, please allow me to too much what to expect from it. I had read Notably, I managed to get some impressions
introduce a smidgen on myself. Like many the experiences of Laura, Allison, and Sally from the attendees on the freelance directory,
medical writers, I did not know this profession (cf. OOOO Vol. 28 Num. 1) with the freelance which eventually set my mind on signing up after
even existed until shortly before falling head over directory, so my only expectation was to get more the summer holidays. That is what to me was
heels into it. A former PhD colleague told me opinions on it from my colleagues. most important at the FBF; networking. Before
about medical writing, and although she was not The first thing that struck me at the FBF was joining EMWA I was not convinced by the power
very specific about what the job entailed – to the wine; after a whole day of workshops running of connections, but how wrong was I! Although
describe it is even hard for some of us to this day on water, some fermented grape juice was most it is not immediate, I have seen word of mouth at
– it still caught my attention. welcome! The most introvert among us, work countless times, so given enough time it can
After my post-doc, when the moment came including me, were really grateful to have a really make wonders. Back to the FBF, I got in
to choose a new career path and after digging up socialisation enhancer. The event started with a contact with some people with whom I am sure
some information on the field, I was completely nice talk by Joanne Hilton followed by an we will be able to establish lasting relations with,
resolved to become a medical/scientific writer. emotional farewell from the Freelance Business be it professional or not.
As some of you may know, a long academic Group by Satyen Shenoy and a short speech by I would never have thought medical writers
background is not always the preferred choice for his successor Laura A. Kehoe. She then would give off that much advice to newcomers
recruiters, but to make matters worse, my degree introduced the table leaders and their topics, and (who are potential competitors), but we stand
is in chemistry, far from the medicine, pharmacy, we were left to discuss and debate for quite some where we are because Homo Sapiens is a
or biology usually required in many job advertise- time. gregarious species. Freelancers tend to work
ments. This meant I got the door slammed in my I was particularly attracted to three topics: alone most of the time, so in the end, my personal
face on several occasions. However, after earning should we get training on day-to-day activities view on the FBF – which could also be extended
AMWA’s Essential Skills Certificate, attending (e.g. accounting, IT); where and how to find new to EMWA – is that we are not alone but instead
EMWA’s internship forum in Barcelona, and clients; and how to get your foot in the door with part of a vast family that believes in mutual aid to
getting tips and advice from well-seasoned regulatory writing. The discussions were vivid, strive.
medical writers, I was finally contacted by and everyone got his or her say in the matter.
someone eager enough to place her trust in me Once the time ran out, the table leaders summed Matías Rey-Carrizo
for a job. up the collective conclusions and we all got some BCN Medical Writing, Spain
Fast forward one year and there I was, an good picture of the addressed topic. In the end, [email protected]

100 | September 2019 Medical Writing | Volume 28 Number 3

Upcoming issues of Medical Writing
December 2019:

Artificial intelligence & digital health

Technological innovation is overtaking all industries, and
medicine is no exception. Artificial intelligence and digital
health are growing trends. As medical writers, we must
understand and communicate these advances and know
how they will affect our profession.

Guest Editors: Evguenia Alechine and Martin Delahunty

March 2020:

Visual communications
Medical communications frequently include a visual component
to aid in transmitting difficult concepts and articulating ideas.
Graphics are crucial to translate the growing amounts of data
available and to quickly communicate information in digital tools.
Medical writers should understand how to visually engage the
reader, either by preparing their own graphic material or
collaborating with design or illustration professionals.

Guest Editor: Ana Goios

The deadline for feature articles is December 10, 2019.

June 2020:

The data economy

In an increasingly digitised world, data are economic assets that
are becoming the lifeblood of the world economy. Medical
writers need to know how the data economy affects the devel-
opment of healthcare products and should understand which
big data repositories are reliable, the specialised data analysis
approaches needed, and the issues around big data protection.

Guest Editors: Raquel Billiones and Sam Hamilton

The deadline for feature articles is March 10, 2020.

CONTACT US

●
✒
If you have ideas for themes or would like to discuss
any other issues, please write to [email protected].

www.emwa.org Volume 28 Number 3 | Medical Writing September 2019 | 101

 http://journal.emwa.org/

98 | March 2019 Medical Writing | Volume 28 Number 1