MDCRC 6040 - Design and Implementation of Clinical Trials

This course defines clinical trails and reviews drug registration trails, phase I, II and II trials, clinical endpoints, surrogate endpoints, pharmacokinetics, drug-drug interactions, data and safety monitoring, criteria for closure and single versus multi-institutional trials. Case-based sessions covering clinical trails in occlusive heart disease, arthritis, asthma, kidney disease and oncology provide informative examples of trail design and potential pitfalls.