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Augments 340.645, Introduction to Clinical Trials. Describes practical aspects of conducting clinical trials and delves deeper into design and analysis concepts introduced in the introductory course. Consists of three modules: Procedural, Design, and Interpretation of Results. The first module reviews key regulatory, ethical and procedural requirements for conduct of clinical trials, including an overview of the FDA drug approval process, review of Good Clinical Practice Procedures, IRB and OHRP requirements and HIPAA regulations, and principles of data acquisition, management, and distribution in the clinical research environment. The second module discusses different designs for clinical trials including translational and dose finding/ranging trials, comparative effectiveness trials, and Bayesian and adaptive designs. Topics include methods for addressing missing data. Also included are lectures that discuss the role, responsibilities and operations of Data Monitoring Boards as well as statistical approaches to interim data monitoring. Discusses key features of systematic reviews and how they can be used for synthesis of the evidence for clinical trials.