INTRODUCTION

CLINICAL RESEARCH-DEFINITION

Clinical research is the study of health and illness in people. It is the way we learn
how to prevent, diagnose and treat illness. Clinical research describes many different
elements of scientific investigation. Simply put, it involves human participants and helps
translate basic research (done in labs) into new treatments and information to benefit patients.
Clinical trials as well as research in epidemiology, physiology and pathophysiology, health
services, education, outcomes and mental health can all fall under the clinical research
umbrella.

CLINICAL TRIALS
A clinical trial is a type of clinical research study. A clinical trial is an experiment
designed to answer specific questions about possible new treatments or new ways of using
existing (known) treatments. Clinical trials are done to determine whether new drugs or
treatments are safe and effective. Clinical trials are part of a long, careful process which may
take many years to complete.

HISTORY

India has recently been recognized as an attractive country for clinical trials. But the
country's journey in clinical research field has a long history. India has a rich heritage of
traditional medicine – Ayurveda. The classic Ayurvedic texts contain detailed observations
on diseases and in-depth guidance on remedies. It is likely that these descriptions are based
on direct observations made by the ancient Ayurveda experts. However, there is no recorded
documentation in the ancient texts of any clinical experiments. Hence, one has to fall back on
current history of medical research in India.
The major historic milestones of the Indian Council of Medical Research reflect, in
many ways, the growth and development of medical research in the country over the last nine
decades. First meeting of the Governing Body of the Indian Research Fund Association
(IRFA) was held on November 15, 1911 at the Plague Laboratory, Bombay, under the
Chairmanship of Sir Harcourt Butler.
At the 2nd meeting of the Governing Body in 1912, a historic decision was taken to
start a journal for Indian Medical research. Between 1918--20, several projects on beriberi,

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malaria, kalaazar and indigenous drugs were initiated. In 1945, a Clinical Research Unit – the
first research unit of IRFA attached to a medical institution was established at the Indian
Cancer Research Centre, Bombay. In 1949, IRFA was re-designated as the Indian Council of
Medical Research. Over next 60 years, ICMR established many national research centers in
the fields of nutrition, tuberculosis, leprosy, viral disease, cholera, enteric disease,
reproductive disorders, toxicology, cancer, traditional medicine, gas disaster, genetics, AIDS
etc.
The Central Ethical Committee of ICMR on Human Research constituted under the
Chairmanship of Honorable Justice (Retired) M.N. Venkatachaliah held its first meeting on
September 10, 1996. Several subcommittees were constituted to consider ethical issues in
specific areas e.g., Epidemiological Research; Clinical Evaluation of Products to be used on
Humans; Organ Transplantation; Human Genetics, etc. The committee released Ethical
Guidelines for Biomedical Research on Human Participants in 2000 which were revised in
2006.
Schedule Y of Drugs and Cosmetics Act came into force in 1988 and established the
regulatory guidelines for clinical trial (CT) permission. The schedule did force the industry to
conduct Phase III clinical trials for registration of a new drug and supported growth of a
predominantly generic Indian pharmaceutical industry. However, this schedule only
permitted clinical trials at a phase lower than its global status. This phase lag obstructed
integration of India in global clinical development.
The next major step has been revision of Schedule Y in Jan 2005. As compared to
Schedule Y 1988, which had narrow and restrictive definitions of clinical trial phases, the
amended Schedule Y 2005 provided pragmatic definitions for Phase I to IV. The definitions
and guidelines for clinical trial phases are broad and rational. The earlier restrictions on
number patients and centers in early phases stipulated in Schedule Y 1988 were removed
allowing the sponsor company freedom to decide these in relation to protocol requirements.
The phase lag requirements gave way to acceptance of concurrent Phase II-III as part of
global clinical trials.
Schedule Y 2005 legalized Indian GCP guidelines of 2001. This schedule stipulated GCP
responsibilities of ethics committee (EC), investigator and sponsor and suggested formats for
critical documents e.g. consent, report, EC approval, reporting of serious adverse event.

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TYPES OF CLINICAL TRIALS

 It means medical research studies involving people. They are divided into different
stages called phases.
 The earliest phase trials might focus at whether a drug is safe or the side effects it
causes. A later phase trial aims to test and compare whether a new treatment is better
than existing ones, also check why clinical trials are important in clinical research.

Based on the behavior of researches

 Clinical observation study

 Intervention study

Clinical observation study

The investigators observe the subject and measure their outcomes. They don’t actively
manage the study. The people taking part aren’t put into treatment groups. The research team
observe the people taking part, but they don’t influence what treatments people have. Aim is
to find out what happens to people in different situations.

CLINICAL
TRIALS

CLINICAL
INTERVENTION
OBSERVATION
STUDY
STUDY

Intervention study

 The investigators give the research subjects a particular medicine to compare the
treated subjects a particular medicine to compare the treated subjects with those
receiving no treatment or the standard treatment.
 Based on inferences the investigator measures the health changes if any.
 Aim is to find out more about a particular intervention, or treatment. A computer puts
people taking part are put into different treatment groups.

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The U.S. National Institutes of Health (NIH) organizes trials into five different types

CLINICAL TRIALS

PREVENTION TRIALS

SCREENING TRIALS

DIAGNOSTIC TRIALS

TREATMENT TRIALS

SUPPORTIVE CARE TRIALS

EXPANDED ACCESS TRIALS

FIXED TRIALS

ADAPTIVE TRIALS

Prevention trials

It attempts to find better ways to prevent diseases in people who were never susceptible or to
prevent a disease from returning.

 These approaches include medicines, vitamins, vaccines, minerals, or lifestyle

changes.
 An example of a prevention trial is the (International Breast Cancer Intervention
Study)IBIS 2 breast cancer prevention trial is the IBIS 2 breast cancer prevention
trials.

Screening trials

 The best way to detect certain diseases or health conditions.

 The study of causes and patterns of disease is called epidemiology.
 Most epidemiological studies are observational studies.
 There are three types of observational studies – cohort studies, case control and cross
sectional studies.

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Diagnostic trials

 To find better alternative for diagnosing a particular disease or condition. For example
to study tests or procedures that could be used to identify cancer more accurately.
 Diagnostic trials usually include people who have sign or symptoms of the disease.

Treatment trials

 It efforts testing experimental treatments, new combinations of drug, or new

approaches to surgery or radiation therapy. They are conducted with diseased people
as test subject.
 They aim answering specific questions about and evaluate the effectiveness of a new
treatment or a new drug or a new approach of using a standard treatment.

Supportive care trials

 It attempts find the quality of trials. It aims finding ways to improve the comfort and
quality of life for individuals with a chronic illness.

Expanded access trials

 Also known as a compassionate use trails. It provides partially tested, unapproved

therapeutics to small number of patients who have lost all realistic options. Usually
this involves disease for which no effective therapy has been yet approved.
 A third classification is whether the trial design allows changes based on data
accumulated during the trial.

Fixed trials:

 It considers existing data only during the trial’s design, and does not modify the trial
after it begins and even not accesses the results until the study is complete.

Adaptive clinical trials

 This use existing data to design the trial and then use inferred results to modify the
trials as it proceeds. Modifications include dosage, sample size, drug undergoing trial,
patient selection criteria and “cocktail” mix.
 Adaptive trials often employ a Bayesian experimental design to assess the trial’s
progress.

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PHASES OF CLINICAL TRIALS

Phase I

 Phase I Clinical Trials are generally conducted in healthy volunteers.

 They are also called as ‘first in human studies’ as it is for the first time that the (New
Chemical Entity) NCE is administered to humans.
 This is the first time that the NCE will be administered to human beings.
 The main purpose of the phase I of clinical new drug development is to determine a
safe dose of the NCE for subsequent studies and to evaluate its side effects in humans.
 Before enrolling volunteers into such studies, the investigators screen the volunteers
by doing thorough physical examination, taking a detailed medical/drug/family
history and conducting a battery of biochemical and other lab tests.

The clinical research of the new drug development starts with permission from the
regulatory authorities. The studies Clinical trials are generally conducted in human
volunteers.

Phase II

 It is important to know whether the drug will produce some toxicity in patients that
was not observed in normal volunteers.
 This is determined by administering the drug to patients with the target disease.

Phase III

 Phase III is the confirmatory phase of new drug development.

 As the larger number (ten thousand or even more) of participants are required for
these studies.

Phase IV

 The process of new drug development does not stop here.

 Research on the marketed drug continues to be carried out as long as the drug stays on
the market. This includes both basic (animal) and clinical research.
 This is also called as “Post Marketing surveillance”. Pharmaceutical companies
marketing a new drug are legally bound to conduct some phase IV studies.

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 Phase 0 Phase I Phase II Phase III Phase IV
“Explanatory”

Description First-in-man Initial safety Begin to Final Any trials

early trial to evaluations, to explore confirmation conducted
determine if determine safe efficacy while of safety and after FDA
drug engages its dosage range, maintaining efficacy. approval of
expected target to identify safety. the drug.
common side
effects, to
study toxicity
profile of the
drug.
Number of 10 – 15 healthy 20 – 80 healthy 100 – 300 1,000 – 3,000 Number of
subjects volunteers. volunteers. volunteers subjects with subjects
with the the targeted depend on
targeted medical trial
medical condition. endpoints.
condition.
Dose Single, low dose -Single dose Multiple dose Multiple dose Variable.
(<1% of dose -Single trials, often trials,
calculated to ascending dose conducting ascending
produce a -Multiple against doses.
clinical effect) ascending dose placebo.
Endpoints Not expected to Escalating of Explores Confirms Confirms
show clinical dose ends clinical effects clinical clinical
effect or when against the efficacy of the efficacy and
significant unacceptable targeted drug against safety and
adverse effects. side effects condition, and the targeted explores
Helps to choose occur; the revels the less condition and other
between previous dose common side evaluates possible drug
competing is considered effects. safety and side uses; may be
chemical the maximum effects. required as a
analogs for tolerated dose. condition of
further study. drug
approval.
Timing Can be Together with Conducted Conducted Conducted
conducted with Phase 0 trials, after report to after report to after a
prior approval first clinical FDA of results FDA of result release of the
while final IND trials of Phase I of Phase II drug by the
review is conducted in trials. trials. FDA for
pending. an IND marketing.
process.

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Essential Documents for the Conduct of a Clinical Trial

 Essential documents are those documents which individually and collectively permit
evaluation of the conduct of a trial and quality of the data produced. These documents
serve to demonstrate the compliance of the investigator, sponsor and monitor with the
standards of Good Clinical Practice and with all applicable regulatory requirements.

 They serve for a number of important purposes

i. Filling essential documents
ii. Essential for audit
iii. Inspected by regulatory authorities
iv. Confirms validity and integrity of data collected

PROTOCOL

A protocol is a detailed statement of the plan of the clinical trial. Protocol includes the
following:

 Objective of the study

 Number of patients to be included
 Criteria for selection of patients
 Design of study, duration of study
 End points to be used, (healing of ulcer, disappearance of pain etc.)
 Laboratory studies – hematological and biochemical tests
 Recording of results and adverse reactions.

An important aspect or the basis of clinical trials lies in the informed consent of the
volunteer. It is crucial that individuals receive and clearly understand the information given to
them before agreeing to participate in a clinical trial. Patients must be aware the trial
including medical procedure and the possible risks and benefits. The Drugs and Cosmetics
Act 1945 gives the format of patient consent form in Schedule Y Appendix V.

Data obtained from controlled clinical trials of investigational new drugs can serve as the
basis for the drug marketing application.. The primary intent of a treatment IND/protocol is to
provide for access to new drug for people with life threatening or serious disease for which
there is no good alternative treatment. It also helps in generation of additional information
about the drug especially of its safety.

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MONITORING OF CLINICAL TRIAL

In monitoring a clinical trial, several factors must be considered.

These include:

1) Ethical considerations
2) Compliance
3) Safety
4) Documentation

1) Ethical consideration

As per Helsinki’s declaration, no patient should be included in a trial without having

the purpose of the trial explained to him in such a way that he is fully informed of what is
going to happen to him.

2) Compliance

In any trial, a proportion of patients will fail to take their tablets, i.e. they will not
comply with the treatment schedule. This can be minimized by ensuring that the patient
understands what is required of him, both by explanation and by clear labeling of bottles. An
instruction sheet may be helpful. Further, random samples of blood and urine should be taken
for analysis, to see if there is any drug present in it.

3) Monitoring for safety

All drugs have unwanted effects, some minor, and some life-threatening. If a new
drug is to be studied great care must be taken to ensure that ill effects are recognized so that
appropriate action can be taken. A new drug have fewer side effects than an existing one, it
may be preferable to use it even if it is not more effective. Clinical chemistry and
hematological parameters are measured before starting the trial to provide a baseline and then
at regular intervals thereafter if an abnormality arises it must be considered whether or not it
is drug related. If it is the clinical trial will have to be discontinued.

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 4) Documentation

Formats for recording results and information are carefully designed before the trial.
A good trial should include the following documentation - Patient’s personal data form
includes name and individual identification, age, sex, occupation, history of illness, family
history and previous treatments. patient’s informed consent, a dosage schedule, a form for
recording reason for withdrawal from the trial. For each, one copy of each rating scale or
recording sheet, a side effect scale for each examination. If the condition occurs in discrete
attacks, (example, migraine) a patient’s diary is essential.

Conducting Trial

Clinical trials are planned scientific investigations in groups of human subjects they
are designed to demonstrate the efficacy and safety of any medical treatment procedure or
device intended for use in diagnosis prophylaxis or therapy. Clinical trials form the basis for
therapeutic decisions by all physicians and it is therefore essential that they should be able to
evaluate the results and conclusions of such trials critically. Clinical trials always involve
making comparisons.

There are five basic kinds of comparisons made in clinical trials. Comparisons
between

 The treatment and complete absence of a treatment: drug v/s no drug.

 The test treatment and another treatment known to be without therapeutic effect: drug
v/s established drug.The test treatment and another treatment of established
therapeutic efficacy; test drug v/s established drug.
 Between one form of treatment and another form of the same treatment. Example,
different dose levels for the drug or different routes of administration.Between early
and later effects of the same treatment.

Clinical investigations on new drugs are attempts to place the sequence of events from
the first studies of a new chemical to its final trials in the therapeutic setting prior to its
acceptance and a new therapeutic agent. They are carried out in a number of phases.

Analysis of Result

Once a trial is complete, it is necessary to analyze the result before an inference can
be drawn regarding the relative merits of a treatment. While tabulation of data on visual

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scrutiny of results may give valuable information, the data is subjected to some form of
statistical analysis. The purpose of this is to determine the probability of an observed
difference being due to chance.

Final Report of Clinical Trial

The format for submission of Clinical Trial Report is as follows:

 Title of the trial.

 Name of investigator and institution.
 Objectives of the trial.
 Design of study: Open, single blind or double blind, non comparative or
comparative; parallel group or cross over.
 Number of patients, with criteria for selection and exclusion; whether written
informed consent was obtained.
 Treatments given – drug and dosage forms; dosage regimens; method of
allocation of patients to the treatments, method of verifying compliance, if any.
 Results: exclusion and dropouts, if any with reasons, description of patients with
initial comparability of groups where appropriate, clinical and laboratory
observations on efficacy and safety; adverse drug reactions.

PHARMACIST ROLE IN CLINICAL TRIAL

 Inventories of clinical trial materials must be kept with records of disposition.

 Drug codes and assignment of patients to treatment groups may be done by the
pharmacist in collaboration with the investigator.
 The pharmacists may control the distribution of clinical trial drugs by recognizing
only those investigators specifically named in the research protocol as legitimate
prescribers of the drug.
 The pharmacist may assist the study by recording information relative to the
medications consumed during a study. Recording adverse reaction data on forms
supplied and advising the investigators of possible drug interactions.
 The pharmacist maintains complete drug profile of the drug under investigation.
 In early studies for efficacy, it is common to include a negative control or placebo
control as well as a positive control with an agent having similar activity as the drug
being tested. The pharmacist selects such formulations.

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  The pharmaceutical form of the drug may also influence the design. In vitro studies
should be conducted to decide which formulation provides the most uniform and
complete availability.
 During phase I itself, formulation may be decided and only chosen formulation should
be used during phase II studies. The pharmacist makes an attempt to minimize the
influence of the observer or investigator as a source of bias and for this double blind
studies are conducted.
 The experimenter usually consults a statistician prior to embarking on an extensive
study. Statisticians and investigators along with pharmacists should decide the details
of the design.
 The pharmacist will have the ultimate responsibility for assigning patients to
treatment groups and maintaining a permanent record of the code that can be made
available to the investigator.

JOB OPPORTUNITIES IN CLINICAL RESEARCH

 Clinical research has become a multidisciplinary industry.

 There are numerous institutions with huge facilities serves as the ideal center for
multi-centered clinical trials.
 Clinical research is one of those interesting career options with a faster growth ladder.
 In the field of clinical research, the demand for skilled professionals is growing
rapidly.
 In a span of five-six years entry level, (Clinical Research Associate) CRAs have
progressed to become project managers and higher related options.
There are various job opportunities in the field of clinical research.

They are,

Clinical Research Coordinate (CRC)

 The Clinical Research Coordinator (CRC) is a specialized research professional
working with and under the direction of the clinical Principal Investigator (PI).
 The Principal Investigator is primarily responsible for the overall design, conduct, and
management of the clinical trial, the CRC supports, facilitates and coordinates the
daily clinical trial activities.

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 C CLINICAL RESEARCH COORDINATOR (CRC)
L CLINICAL DATA MANAGER
I
MEDICAL/REGULATORY AFFAIRS
N
I INVESTIGATOR
C BIOAVAILABILITY & BIOEQUIVALENCE EXPERT
A TRIAL SUPPLIES/LOGISTICS MANAGER
L
CLINICAL TRIAL DOCUMENTATION IN-CHARGE
CLINICAL RESEARCH ASSOCIATE (CRA)
R
E PHARMACOVIGILANCE & DRUG SAFETY PROFESSIONAL
S MEDICAL WRITING PROFESSIONAL
E BIOSTATISTICIAN
A
CLINICAL PROJECT MANAGER
R
C QUALITY ASSURANCE AUDITOR
H BUSSINESS DEVELOPMENT PERSONNEL

Clinical Research Associate (CRA)

 Serve as communication link between sponsor and Principal Investigator (PI).
 Train the site staff on protocol procedures and requirements.
 Ensure clinical sites receive study materials and drug (or medical device) supplies.
 Collect regulatory documents.
 Monitor clinical sites, Report and resolve protocol deviations.
 Prepare monitoring reports, Maintain master study file.
 Track and report status of enrolled patients.
 Conduct site close-out visits.
 Arrange for return of experimental drug or medical devices, Archive study
documents.

Clinical Data Manager

 Build and maintain clinical databases.
 Develop case report forms.
 Create data review guidelines.

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  Review clinical data for erroneous, missing, or questionable data.
 Write and validate error checking diagnostics.
 Run data and diagnostic programs and special listings.
 Create data query conventions.
 Produce, track, and resolve queries on problematic clinical data.
 Review clinical study reports
 Manage data management subgroup.

Biostatistician
 Follow the statistical aspects of Good Clinical Practice (GCP) and relevant Standard
Operating Procedures (SOPs).
 Prepare statistical analysis plans.
 Review and approve key study-related documents.
 Write, test validate, and execute software programs to produce datasets and tables,
listings, and graphs for inclusion in clinical reports.
 Perform, present, and interpret statistical analyses.
 Support and facilitate Data Monitoring Committee (DMC) activities.
 Facilitate DMC charter and member selection.
 Coauthor and review statistical section of clinical reports.
 Prepare integrated summaries for MAAs (summary of clinical efficacy, summary of
clinical safety).

Quality Assurance Auditor

 Conduct internal audit of clinical studies.
 Conduct audits of contracted vendors and CROs.
 Ensure compliance with regulatory requirements.
 Ensure compliance with sponsor and vendor SOPs.
 Write audit reports of audit findings
 Manage SOPs, train clinical teams on quality assurance topics.

Clinical safety specialist

 Collect, code, organize, and track suspected adverse events.
 Review safety section of study protocols, ICFs, CRFs, IBs, and study reports.
 Compile annual safety reports, train clinical staff on AE reporting procedures.

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Medical Writer

 Write -
 Clinical protocols, sample, (Informed Consent for Clinical Trials)ICFs,
(Investigators Brochure) IBs, and clinical study reports.
 Annual reports, summaries, and applications for regulatory submission.
 Medical education materials, training aids, and patient information.
 Medical device Instructions for use.
 White papers and company position papers.
 Pharmaceutical marketing and advertising copy.
 Edit and proofread scientific and medical manuscripts, assist scientists and
clinicians in writing abstracts and journal articles.
 Participate in document quality control.
 Draft physician and patient information sheets.
 Lead document review meetings.

Clinical Study Manager

 Manage clinical staff, write clinical protocols, draft sample informed consent form.
 Select clinical vendors, CROs, and other study contractors.
 Oversee investigator and vendor agreements.
 Authorize payments to investigators and vendors.
 Report study progress for management review and regulatory reporting.

Regulatory Affairs Specialist

 Provide regulatory affairs expertise on project and program teams.
 Advice clinical study teams on regulatory issues.
 Compile essential documents for regulatory submission.
 Submit the protocol, final study report, and other required documents to regulatory
agencies.
 Coordinate preparation, submission, and maintenance of regulatory documents for
review and approval.

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Principal Investigator
 A PI need not be a physician.
 Sponsors who design and pay for clinical trials are required by law, to select
individuals who are qualified by training and experience to conduct a clinical trial.
 PI outsources research tasks, such as analysis of blood biomarkers, to contract
research organizations.

Clinical trial documentation In-charge

 Ensure high quality and efficiency of Clinical Document.
 Processing standards in accordance with Good clinical Practices.
 Support the Clinical Document Processing & Archiving Lead to define the strategy
for the Processing activities.

Logistics manager
 Plan, design, and implement inventory management.
 Plans for steady supply chains.
 Ensure supply and resupplies according to study and operations’ needs.
 Identify, recommend, and lead process improvement initiatives.
 Identify potential supply chain.
 Identify supply issues to mitigate risk.

Business development personnel

 Generating and maintaining important business reports
 Representing the organization at various conferences.
 Creating multiple types of marketing tools for advertising.
 Preparing proposals to meet client requirements.
 Generating new business leads
 Securing new business.
 Ongoing relationship building with potential clients.

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PILOT STUDIES

A pilot study, pilot project, pilot test, or pilot experiment is a small-scale preliminary
study conducted to evaluate feasibility, duration, cost, adverse events, and improve upon the
study design prior to performance of a full-scale research project. It is the first step of the
entire research protocol and is often a smaller-sized study assisting in planning and
modification of the main study. It often precedes the main trial to analyze its validity. Before
a pilot study begins, researchers must fully understand not only the clear purpose and
question of the study.

Objectives of a pilot study

 A pilot study is performed reflecting all the procedures of the main study and
validates the feasibility of the study by assessing the inclusion and exclusion criteria
of the participants, preparation of the drugs and intervention, storage and testing of
the instruments, as well as training of researchers and research assistants.
 The researchers as well as the research assistants must fully understand the purpose,
method, procedures of the study and the suitability of the method for data collection
must be tested.

A PILOT STUDY ON ENT DISEASES

INTRODUCTION ON ENT DISEASES

Ear, nose and throat consultants treat a wide range of different conditions that can affect
these connected parts of the body. Infections are one of the most common problems treated
by ear, nose and throat consultants. Many different types of infection can cause ENT
disorders. Injuries to the ear, nose or throat can be very painful and difficult, especially if
they affect your senses or interfere with eating and drinking. The ears, nose and throat all
have essential roles to play including for our senses, speech, breathing and eating.

ENT disorders can sometimes get in the way of these essential functions, causing
symptoms such as:

 Hearing problems including tinnitus and hearing loss

 Difficult swallowing, hoarseness or losing your voice

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  Loss of the sense of taste & smell

 Blocked airways causing snoring or breathing problems.

LITERATURE REVIEW
 A survey of ear, nose and throat disorders in rural India. Amar Singh et al (2010)
The main aim of this survey was to assess the prevalence of common ear, nose and
throat (ENT)disorders in the rural India. In this survey prevalence of ENT disorders in
rural area was 4.31% and ear diseases was the commonest .This was mostly seen in
population from low socioeconomic status. There is lack of facility for proper
management of such patients and more facility as well as education regarding the
diseases and method of prevention is needed.
 Pilot Study to Evaluate the Prevalence of Hearing Loss in a Rural Community.
Lingamdenne Paul Emerson, M.S (ENT)(2016) To identify Hearing loss in the
community Using Portable Dp OAE SCREENER. This study demonstrates the need
for hearing screening at primary level in a rural community. Early detection of
hearing loss is a cost effective and easily operable model is the need of the hour.
Otoacoustic emission testing is one which is easy to use reliable and can be used to
screen large numbers.
AIM
The aim of the Pilot study is to estimate the prevalence of ENT Diseases.
METHODOLOGY
This was a one week randomized observational pilot study carried out in Srinidhi
Pharmacy at Trichy, by collecting prescriptions of ENT Consultant.
 Patients attending the ENT clinics were approached at pharmacy shops and
requested to how their prescriptions and by taking prior consent of the patient’s
prescriptions were copied.
 Information collected by the standard proforma with following inclusion and
exclusion criteria.
INCLUSION CRITERIA
All aged group patients with ENT diseases.
RESULT & DISCUSSION
A total number of 17 prescriptions were collected by using standard proforma. The
collected information were analysed & the following results were obtained:

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 Table No.1 Prevalence of ENT Diseases (n=17)

S. No. Name of the disease Number of patients Percentage

1. Ear diseases 5 29.40%

2. Nasal diseases 6 35.30%

3. Throat diseases 6 35.30%

NOSE - 35.30%
TONGUE - 35.30%
EAR - 29.40%

Figure No.1 prevalence of ENT Diseases

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 Table No.2 Prevalence of Ear disease (n=5)

S. No. Name of the disease Number of patients Percentage

Central perforation middle

1. 1 20.00%
ear mucosa heavy

2. Tinnitus 2 40.00%

3. Vestibular dysfunction 1 20.00%

4. Otomycosis 1 20.00%

CENTRAL PERFORATION
TINNITUS
VESTIBULAR DYSFUNCTION
OTOMYCOSIS

Figure No.2 Prevalence of Ear disease

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 Table No.3 Prevalence of Nose disease (n=6)

S. No. Name of the disease Number of patients Percentage

1. Allergic rhinitis 3 50.00%

2. Mucoid nasal discharge 2 33.00%

3. Allergic rhinitis epistaxis 1 17.00%

ALLERGIC RHINITIS
MUCOID NASAL DISCHARGE
ALLERGIC RHINITIS EPISTAXIS

Figure No. 3 Prevalence of Nose disease

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 Table No.4 Prevalence of Throat disease (n=6)

S. No. Name of the disease Number of patients Percentage

1. Allergic pharyngitis 2 32.00%

2. Vocal cord higic module 1 17.00%

3. Oral ulcer multiple sclerosis 1 17.00%

Obstructive adinotonsillar
4. 1 17.00%
hypertrophy

5. Throat muscle spasm 1 17.00%

ALLERGIC PHARYNGITIS

VOCAL CORD HIGIC MODULE

ORAL ULCER MULTIPLE SCLEROSIS

OBSTRUCTIVE ADINOTONSILLAR
HYPERTROPHY
THROAT MUSCLE SPASM

Figure No.4 Prevalence of Throat disease

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 Table No.5 Overall age categorization of the study population (n=17)

S. No. Age Number of patients Percentage

1. Below 10 3 17.65%

2. 10 – 20 0 0%

3. 20 – 30 3 17.65%

4. 30 – 40 5 29.40%

5. 40 – 50 6 35.30%

BELOW 10
10 to 20
20 to 30
30 to 40
40 to 50

Fig.No.5 Overall age categorization of the study population

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 Table No.6 Overall age gender categorization of study population (n=17)

S. No. Gender Number of prescriptions Percentage

1. Male 11 65%

2. Female 6 35%

MALE
FEMALE

Fig. No.6 Overall age gender categorization of study population

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CONCLUSION

The prime aim of clinical studies are largely to establish:

 The pharmacological properties of the drug in humans i.e. pharmacokinetic and

pharmacodynamic considerations.
 The toxicological properties of the drugs in humans.
 The appropriate route and frequency of administration of drugs in humans.
 They represent a scientific way to test individual agents or procedures to ensure
safety and effectiveness.
 They compare two or more methods, with the objective of constantly improving
current science and discovering better ways to prevent, detect and treat an illness/
disease.
Pilot Study

Out of 17 collected ENT department prescriptions

 5 were ear related disease,

 6 were nose related &
 6 were throat related prescription.
 Most of the patients were affected with allergic rhinitis
 A higher prevalence of ENT diseases was observed in the male patients than the
female patients.
 The prevalence of nose and tongue disease is 5.90% more than the prevalence of ear
disease.
 Patients with ENT diseases are more at the age range of 40 - 50.
 This pilot study will be helpful to evaluate current status of ENT diseases & treatment
schedule.

25
 BIBLIOGRAPHY
BOOKS:
1. CLINICAL PHARMACY – Dr. H. P Tipnis & Dr. Amrita Bajaj (First edition – July
2003)
2. PHARMACEUTICAL REGULATORY SCIENCE – Dr. Ashok A. Hajare (First edition
– January 2021)
3. TEXTBOOK OF CLINICAL RESEARCH – Dr. Vikas Dhikav (First edition – January
2016)

NET SOURCES:
1. https://med.virginia.edu /
2. https://www.researchgate.net/
3. https://wustl.edu/
4. https://www.ncbi.nlm.nih.gov/
5. https://ichgcp.net/
6. https://www.firmaclinicalresearch.com/
7. https://www.jliedu.com/
8. https://www.cancerresearchuk.org/
9. https://www.slideshare.net/
10. https://dysmech.com/
11. https://issuu.com/
12. https://books.google.co.in/
13. https://ww.wikipedia.org/

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 APPENDIX

PROFORMA-I

PATIENT’S DEMOGRAPHIC DETAILS

Patient Name:

Age:

Gender: M / F

Inpatient/Outpatient:

Hospital Name:

Doctor’s Name:

Date of admission/Visit:

Reason for admission/Visit :

Diagnosis:

Associated Diseases:

Allergy (if any):

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