BO4001 Clinical Trials and Bioethics Syllabus:

BO4001 Clinical Trials and Bioethics Syllabus – Anna University PG Syllabus Regulation 2021

OBJECTIVES

 To introduce the fundamentals of clinical trial design and conduction
 Provide the learning of regulations and ethical practice in clinical research.

UNIT I INTRODUCTION TO CLINICAL TRIALS

Fundamentals of Clinical Trials – Introduction to terminology – Clinical Trial Phases – Need of trials – Problems in the Timing of a Trial – Study Protocol – Basic statistics for clinical trials – Clinical trials in practice – Reporting and reviewing clinical trials.

UNIT II REGULATIONS OF CLINICAL TRIALS

Good clinical practice – Principles of ICH-GCP – Responsibilities – Functions – Operations of IRB/IEC – Investigator – Sponsor – Trial protocol and amendment(s) – Investigator Brochure; Legislation and good clinical practice – Overview of the European directives and legislation governing clinical trials in the 21st century – International perspectives of clinical trials.

UNIT III STUDY DESIGN AND POPULATION

Design – Randomized Control Trials – Nonrandomized Concurrent Control Studies – Historical Controls and Databases –Cross-Over Designs – Withdrawal Studies – Factorial Design – Group Allocation Designs – Hybrid Designs – Large, Simple and Pragmatic Clinical Trials – Studies of Equivalency and Noninferiority – Adaptive Designs; Randomization – Fixed Allocation Randomization – Adaptive Randomization Procedures – Mechanics of Randomization; Blinding – Types of Blinding – Protecting the Double-Blind Design – Debriefing of Participants; Recruitment – Considerations Before Participant Enrollment – Conduct – Monitoring; Population – Potential for Benefit – Likelihood of Benefit – Avoiding Adverse Effects – Competing Risk – Avoiding Poor Adherers – Pharmacogenetics – Recruitment of Study Participants.

UNIT IV ETHICAL ISSUES

Planning and Design – Ethics Training – Randomization Control Group – Protection from Conflicts of Interest – Informed Consent – Conduct – Trials in Low and Middle Income Countries – Recruitment – Safety and Efficacy Monitoring – Early Termination for other than Scientific and Safety Reasons – Privacy and Confidentiality – Data Falsification.

UNIT V QUALITY CONTROL AND ASSURANCE & DATA ANALYSIS

Quality control and assurance procedures – Performance monitoring – Training procedures – Assurances and certifications – Site visiting procedures – Audit procedures; Analysis datasets – Frequentist vs Bayesian analysis – Final analysis – Subgroup analysis; Pharma covigilance; Research governance; Trial closure and pitfalls-trial closure; Reporting and legal requirements; Common pitfalls in clinical trial management.

TOTAL: 45 PERIODS

COURSE OUTCOMES:

 Acquire the fundamentals of clinical trials and the way of preparation of study protocol.
 Know the implementation of guidelines and responsibilities of various stakeholders of clinical trials.
 Learn the way of design of study and recruitment procedures of study participants.
 Know the ethical practices of acquirement of informed consent and trial conduction.
 Learn to assess the quality of clinical trials through monitoring and auditing procedure.

REFERENCES:

1. Lawrence M.Friedman et. al, “Fundamentals of Clinical Trials”, Mosby,1996
2. Curtis L Meinert et. al, “Clinical Trials – Design Conduct and Analysis”, Oxford University, 2012.
3. ICH – Harmonised Tripartite Guideline – Guideline for Good Clinical Practice E6 (R1) – Current Step 4 version – dated 10 June 1996.
4. Lee, Chi-Jen et. al, “Clinical Trials or Drugs and Biopharmaceuticals.” CRC/Taylor & Francis, 2011.
5. Matoren, Gary M. “The Clinical Research Process In The Pharmaceutical Industry. “Marcel Dekker, 1984.