4.Clinical Trail Protocal and IRB or IEC.pptx
- 1. CLINICAL TRIAL PRTOCAL & IRB/IEC 1 Mr.B.Brahmaiah Assistant Professor Department of Pharmaceutical Regulatory Affairs & Pharmaceutics Shri Vishnu College of Pharmacy, Bhimavaram
- 2. Content 2 Introduction T rial Protocol Institutional Review Board/Independent Ethics Committee (IRB/IEC) Composition of IRB/IEC Members of IRB/IEC Responsibilities of IRB/IEC Procedures of IRB/IEC Maintenance of records of IRB/IEC Reference
- 3. Introduction 3 What is a Clinical trial? ⚫ prospective ethically designed investigation in It human subjects to discover/verify/compare the results of two or more therapeutic measures (drugs) ⚫ A clinicaI trial is a planned experiment that involves volunteers/patients ⚫ Aim to compare the response to new treatment with that of an existing one ⚫ Clinical trial is just apart of New Drug Discovery Process.
- 4. Why are clinical trials important? 4 ⚫ Clinical trials translate results of basic scientific research into better ways to prevent,diagnose,or treat disease ⚫ The more people take part,the faster we can: o Answer critical research questions o Find better treatments and ways to prevent disease
- 5. Trial Protocol : 5 It is a complete written description and scientific rationale for a research activity involving human subjects. ◦ TITLE PAGE ◦ SIGNATURE PAGE ◦ CONTENT PAGE ◦ LIST O FABBREVIATIO NS ◦ INTRODUCTION/ABSTRACT ◦ OBJECTIVES ◦ BACKGROUND/RATIONALE ◦ ELIGIBILITY CRITERIA ◦ STUDY DESIGN/METHODS (INCLUDING DRUG/DEVICE INFO) ◦ SAFETY/ADVERSE EVENTS ◦ REGULATORY GUIDANCE ◦ STATISTICAL SECTION (INCLUDINGANAL YSISAND MONITORING) ◦ HUMAN SUBJECTS PROTECTIONIINFOR11ED CONSENT
- 6. TITLE PAGE : 6 ⚫ Title page introduce the document ,its title,precise number ,sponsor and author to the reader . ⚫ Protocol identifying number and date. ⚫ The protocol number must clearly indicate the version number ,whether it is final or draft and date of this version.
- 7. Title page should includes: ⚫ Full title should include summary study design,medicinal products ,nature of treatment (eg :treatment and diagnosis) indication patient population setting (eg :in-patient,outpatient) Randomised double bind multiple studies. ⚫ Name and address of sponsor and monitor. Sponsor names and list of responsibilities with agreed allocations ⚫ Name and address of the authorised person to sign the protocol and protocol amendment for the sponsor. Generally, chief investigator for trial or principle investigator for single center trials. ⚫ Name ,title,address and telephone number of the sponsor medical expert for the trial ⚫ Name and title of the investigator who is responsible for conducting the trial,and the address and telephone number of the trial site. ⚫ Name, title, address and telephone number of the qualified physician who is responsible for all trial site related medical decisions. ⚫ Name and address of the clinical laboratory and other medical or technical or institutions involved in the trial. 7
- 8. SIGNATURE PAGE : 8 Signature page of all healthcare professionals in the trial including contact details of participating site,sponsor and sponsor medical advisor if not already given above. CONTENT PAGE : This help navigation through the document by large number of different people that will be needed throughout the trial.
- 9. LIST O F ABBREVIATIONS : 9 All abbreviations used should be listed and defined. Accepted international medical abbreviations should be standardised within each project. INTRODUCTION / ABSTRACT : This summary should be only one to two pages long.It should give the reader sufficient information to understand the rationale for the trial,its objective and the methods that will be used to achieve these objective.
- 10. OBJECTIVES : 10 ⚫ Objectives should be stated clearly as hypotheses to be tested. ⚫ Each objective should have a corresponding discussion in the statistical section. BACKGRO U N D AND RATIONALE : ⚫ All protocols require a section detailing the scientific rationale for a protocol and the justification in medical and scientific literature for the hypothesis being proposed. ⚫ Introductory section should be organized in a logical,sequential flow .
- 11. ELIGIBILITY CRITERIA - DEFINITION : 11 ⚫ Inclusion and exclusion criteria are the conditions that must be met in order to participate in a clinical triaI. ⚫ The most important criteria used to determine appropriateness for clinical trial participation include age,sex,the type and stage of a disease,treatment history,and other medical conditions.
- 12. STUDY DESIGN : 12 ⚫ The design study section of the protocol should contain a stepwise description of all procedures that required to by study. ⚫ A good study design section includes sufficient information for the participating site. ⚫ Parts of the study design section may include: ◦ Initial evaluations ◦ Screening tests ◦ Required lab tests ◦ Details of treatment or procedures ◦ Device specifications ◦ Dose scheduling and modification ◦ Calendars
- 13. SAFTEY : 13 ⚫ Adverse effect and side effect are terms commonly associated with drugs.They are used by nurses and doctors, to refer to undesirable effects of a medication on a patient. ⚫ The Safety (orAdverse Events) section should include: ◦ Detailed information for reporting adverse events, including reporting to the FDA and/or the sponsor ◦ Unblinding processes (if applicable) ◦ Lists of expected adverse events
- 14. THE STATISTICAL SECTION: ⚫ The study objectives and study design elements in the statistical section should be described in the Objectives section ⚫ The descriptions and definitions of toxicities in the statistical section match those in the Safety/AE section. H U M A N SUBJECTS PROTECTION : ⚫ •This section includes discussion of: ◦ Subject selection and exclusion ◦ Proposed methods of patient recruitment ◦ Minority representation ◦ Recruitment (or exclusion) of special subjects,including vulnerable subjects ◦ Lists of potential risks and benefits,including justification for risks. 14
- 15. Institutional Review Board / Independent Ethics Committee (IRB/IEC) : 15 ⚫ IRB/IEG serves as an independent body that reviews, evaluates,approves and decides on the scientific and ethical aspects of the clinical trial protocol as well as the benefits and risks to the study participants ⚫ Main purpose of IRB/IEG is to protect the rights,safety , and well-being of the subjects who participate in a trial
- 16. Composition of IRB/IEC : 16 ⚫ Consists of members,who collectively have the qualifications and experience to review and evaluate the science,medical aspects,and ethics of the trials. ⚫ Includes at least five members,of which at least one member whose primary area of interest is non- scientific,and at least one member who is independent of the institution/trial site.
- 17. MEMBERS OF IEC 🠶 Chair person 🠶 1-2 basic medical scientists 🠶 1-2 clinicians from various institutes 🠶 One legal expert or retired judge 🠶 One social scientist 🠶 One philosopher/ethicist 🠶 One lay person 🠶 Member Secretary
- 18. Responsibilities of IRB/IEC : 18 ⚫ Safeguard the rights,safety ,and well-being of all trial subjects. ⚫ Reviews a proposed clinical trial within a reasonable time and document its views in writing. ⚫ Conducts continuing review of each ongoing trial at least once per year . ⚫ Ensures that information regarding payment to subjects (including the methods,amounts,schedule of payment) is set forth in the written informed consent form and any other written information is provided to the subjects.
- 19. Procedures of IRB/IEC : 19 ⚫ Determines its composition and authority under which it is established. ⚫ Schedules,notifies its members of,and conducts its meetings. ⚫ Conducts initial and continuing review of trials. ⚫ Specifies that no subject should be admitted to a trial before the IRB/IEC issues its written approval or favorable opinion of the trial. ⚫ Specifies the information that the investigator should report to the IRB/IEC (like deviations from the protocol,adverse drug reactions etc).
- 20. Maintenance of records of IRB/IEC : 20 ⚫ IRB/IEG retains all relevant records (e.g.,written procedures,lists of occupations/affiliations of members, submitted documents,minutes of meetings,etc.) for a period of at least 3 years after complet of the trial and makes them available upon request from the regulatory authority(ies) ⚫ IRB/IEG may be asked by investigators,sponsors, or regulatory authorities to provide copies of its written procedures and membership lists.
- 21. References : 21 https://www.slideshare.net/mobile/ssuserfe3019/clinical- trial-protocol-development Assessed Date:25/02/2021 https://www.slideshare.net/mobile/TSDP/institutional- review-boardindependent-ethics-committee-irbiec Assessed Date:25/02/2021 https://www.slideshare.net/mobile/ChintanDoshi17/clini cal-trial-120090206 Assessed Date:25/02/2021 https://www.slideshare.net/mobile/uttara2024/clinical- trials-types-and-designAssessed Date:25/02/2021
- 22. THANK YOU 22