Meeting location information can now be found on student schedules in ESTHER (for students) or on the Course Roster in ESTHER (for faculty and instructors).
Description: 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 prepare the student to read the clinical trial literature critically and to design clinical 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.