BIOS 6326 Methods of Clinical Trials

3 SCH. The course covers the general concepts and methods in clinical trials. Topics include phase I, II, and III clinical trials, basic study design, ethical considerations, organization, study population, patient recruitment, protocol adherence and compliance, adverse events, data management, closeout, issues in reporting results, as well as statistical techniques such as designs for phase I, II, and III clinical trials, randomization, blindness techniques, sample size determination, interim analysis, analysis of safety data, intent-to-treat analyses, adaptive designs, multiple endpoints, Bayesian approaches, and sequential designs. Prerequisite: BIOS 5310 or BIOS 5311. Offered every other Spring-Even Years. Letter Grade