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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.
This noncredit class meets with a regular University of Utah credit course.