Faculty of Science

Objectives

To acquire knowledge and skills required in the professional conduct of a clinical trial.

Contents

This course covers various topics in the design, conduct, analysis and interpretation of clinical trials and uses published and on-going studies to illustrate these issues. Topics include the definition and history of clinical trials; trial designs, including phase I-IV, parallel, crossover, factorial, and large multicenter trials; internal and external validity; selection of intervention, control, and study population; randomization and masking; selection of trial outcome variables; data collection and quality control; ethical issues; data analysis principles; and issues related to publication and dissemination. Pharmacogenomics and its role in modern clinical trials.