Course Schedule and Catalog

Department: Statistics

Grade Mode: Standard Letter

Course Type: Lecture

Credit Hours: 3

Description: TOPICS IN CLINICAL TRIALS ***** This course deals with fundamental concepts in the design of clinical stuides, ranging from early dose-finding studies (phase I) to screening studies (phase II) to randomized comparative studies (phase III). The goal is to prepare the student to read the clinical trial literature critically and to design cilinical studies. Additionally, the faculty will introduce newer designs for clinical studies that incorporate prior knowledge and/or satisfy optimality considerations. Topics include protocol writing; randomization; sample size calculation; study design options; interim monitoring; adaptive designs; multiple end points; and writing up the results of a clinical trial for publication.