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, and issues in reporting results. Additionally, it covers statistical techniques such as randomization, blindness techniques, sample size determination, analysis of safety data, intent-to-treat analyses, adaptive designs, multiple endpoints, quality of life, survival analysis, and meta-analysis.
Prerequisite: Student must complete BIOS 5310.
Offered Fall and Spring
Letter Grade