BIOS 6318 Clinical Trials and Survival Analysis

3 SCH. This course covers the general concepts and methodologies in clinical trials and statistical techniques in survival analysis. Topics covered include: phase I, II and III clinical trials, basic study design, ethical considerations, organization, study population, patient recruitment, protocol adherence and compliance, adverse event, 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, and interim analysis. In addition, survival analysis will cover survival distributions, censored data, Kaplan-Meier curve and life-table analysis, logrank test, hazard function, and the Cox regression. Prerequisites: BIOS 5300 and BIOS 5310 or obtain permission from the instructor. Offered Spring. Letter Grade