Course Detail
Units:
2.0
Course Components:
Lecture
Enrollment Information
Enrollment Requirement:
Prerequisites: MDCRC 6000 or equivalent.
Description
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.