CLINICAL EVENTS COMMITTEE

The Thrombolysis in Myocardial Infarction (TIMI) Study Group Clinical Events Committee (CEC) provides comprehensive clinical endpoints services for cardiovascular clinical trials and registries. The CEC has supported both TIMI and non-TIMI led projects, and has adjudicated clinical events for trials that have resulted in successful New Drug and New Indication Applications for the US Food and Drug Administration and world-wide regulatory agencies. Trials have ranged from fewer than 100 events to more than 20,000 events adjudicated. The CEC services includes data management, document collection, document hosting, medical review and adjudication services. Current trials employ a paperless electronic clinical events adjudication system that allows for rapid communication, adjudication and archiving of events. A major strength of the TIMI CEC is that it utilizes a core group of experienced, board-certified, attending-level specialists for adjudication services. Physician specialties include interventional and general Cardiology, Neurology, Oncology, Endocrinology, and Hepatology to provide broad expertise across safety and efficacy events encountered in clinical trials. The TIMI CEC is chaired by Dr. Stephen D Wiviott, and directed by Ms. Cheryl Lowe. Dr. Wiviott is a recognized expert in clinical trials, clinical endpoint definitions and adjudication serving on national committees with academics, industry and regulators to define and standardize and evaluate clinical event definitions across cardiovascular clinical trials.