Clinical Trials

Dr. Pavani, VCOP

 Introduction
• Clinical trial is a systematic investigation in human
subjects for evaluating the safety & efficacy of any new
drug.
• Clinical trials are a set of tests in medical research and
drug development that generate safety and efficacy
data for health interventions in human beings.
• 3. Research studies involving people: Try to answer
scientific questions and find better ways to prevent,
diagnose, or treat disease. Translate results of basic
scientific research into better ways to prevent,
diagnose, or treat disease
 Developing clinical trial protocol
• A research protocol is a document that describes the background, rationale, objectives, design,
methodology, statistical considerations, and organization of a clinical research project. According to the
ICH Good Clinical Practice guidelines, a protocol should include the following topics:
• Title Page (General Information)
• Background Information
• Objectives/Purpose
• Study Design
• Selection and Exclusion of Subjects
• Treatment of Subjects
• Assessment of Efficacy
• Assessment of Safety
• Adverse Events
• Discontinuation of the Study
• Statistics
• Quality Control and Assurance
• Ethics
• Data handling and Recordkeeping
• Publication Policy
• Project Timetable/Flowchart
• References
• Supplements/Appendices
 IRB/IEC
• Institutional Review Board/Independent Ethics Committee (IRB/IEC) •
IRB/IEC 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/IEC is to protect the rights, safety, and well-being of the
subjects who participate in a trial
• Composition of IRB/IEC
• Responsibilities of IRB/IEC
• Procedures of IRB/IEC
• Maintenance of records IRB/IEC