MDCRC 6040 - Design and Implementation of Clinical Trials

This course defines clinical trials and reviews drug registration trials, phase I, II and III 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 trials in occlusive heart disease, arthritis, asthma and oncology provide informative examples of trial design and potential pitfalls.