Introduction to Clinical Trials: Design, Conduct, and Analysis

This course covers basic concepts in the design, conduct and analysis of clinical trials. Various phases and designs of clinical trials will be discussed. Components of a trial protocol and the statistical analysis plan will be discussed. Data collection, management, and study monitoring for the conduct of clinical trials will be addressed. The roles of the Institutional Review Board (IRB), Data Safety Monitoring Board (DSMB) and federal regulatory agencies in the approval and review of ongoing clinical trials will be discussed. Students are assumed familiar with topics taught in introductory statistics (summary statistics, hypothesis testing, p-values, confidence intervals, and regression). Prereqs: An introductory course in statistics/biostatistics or consent of instructor.