Clinical Trials Design

This course will provide students with basic understanding of clinical trials design, and will review techniques used to prevent potential bias that could impact the approval of a new drug to the market. Topics include Phase I to IV trials, project team roles, trial methodology, and regulatory requirements. Processes and components of protocol development will include synopsis, hypothesis, scientific rationale, study objectives, sample size, endpoints, procedures, safety, ethical considerations, and analyzing and reporting the results. Quality of life, pharmacoeconomics, management of clinical supplies, and new technology will also be discussed.