BIOS5005 Clinical Trials

The objective of this course is to provide students with a theoretical and practical knowledge of the issues involved in the design, conduct, analysis and interpretation of randomized clinical trials. We will discuss the basic principle of randomization and its importance, proper randomization and blinding procedures, choice of control arm, the importance of clear definition of endpoints, methods to calculate sample size, other statistical considerations and ethical issues in clinical trials. Attention will be given to the problems of conducting clinical trials in both single center and multi-center, and covers trials initiated by industry as well as trials in academic setting. Students will be trained to develop skills to properly design clinical trial, critically analyze and carry out research and to communicate effectively.


Week Topics
1 Overview of Clinical Research Methods, Role and Techniques of Randomization, Blinding, Outcome Measures
2 Clinical Trial Design, Interventions and Controls (Placebo), Design Issues in Non-inferiority Trial, Other Special Designs (e.g. Crossover, Factorial)
3 Problem of Non-compliance, Protocol, Data Collection and Quality Assurance, Data Management, Critical Appraisal of Trial Results
4 Students Presentation of Synopsis of Trial Protocol
5 Survival Analysis, Intention-to-treat Principle, Stratification, Covariate Adjustment, Interaction, Subgroup Analysis
6 Sample Size, Interim Analysis, Data and Safety Monitoring
7 Introduction to ICH GCP in Clinical Trials, Serious Adverse Event Reporting, Essential DocumentsSynopsis of Trial Protocol Due
8 Presentation and Cluster Randomization Trials
9 Final Exam