GS010813   Topics in Clinical Trials

Lee, Jack J. Three semester hours. Spring odd numbered years. Prerequisite: Prior courses in probability and statistics, permission of the instructor

This course deals with fundamental concepts in the design of clinical studies ranging from early dose-finding studies (phase I) to screening studies (phase II) to randomized comparative studies (phase III). The goal is to teach the statistical issues involved in clinical trials, to introduce various clinical trial designs, and to prepare the student to read the clinical trial literature critically. Additionally, the faculty will introduce newer designs for clinical studies that incorporate prior knowledge and/or satisfy optimality considerations. Topics include basic study design options, sample size calculation, randomization, trial conduct, interim monitoring, data analysis, adaptive designs, multiple endpoints, meta-analysis, decision analysis, Bayesian methods, innovative phase I, II trial designs, and writing up the results of a clinical trial for publication.