The CEC Core Lab provides an independent, blinded determination of trial endpoints or events, a critical factor in the acceptance of the results by the FDA and the academic and medical communities. The CEC facilitates a timely review of cases identified as having potential endpoints. The CEC process is coordinated by a CEC Research Nurse (CEC RN) with a support infrastructure of Research Coordinators.

Clinical Events Committee Process
An experienced, cardiovascular CEC Research Nurse (CEC RN) oversees each clinical study and tailors the CEC process to study-specific needs. This includes reviewing and providing input into the clinical trial protocol, developing endpoint definitions, identifying and training reviewers in conjunction with the Principal Investigator and/or CEC Medical Directors, and coordinating all aspects of the review process with the sponsor, CRO and other involved parties.

Potential endpoints are typically based on investigator identified events as well as those identified from specific triggers from the case report form.

Typically, Phase I review for cardiology endpoints consists of two independent physician reviewers. Phase II review consists of one to three Staff Cardiologists who adjudicate the case (the number of reviewers is study-specific and approved by sponsor). The CEC maintains the highest standards for reviewer accuracy and consistency. This quality is assessed on an ongoing basis throughout the clinical trial.

Clinical Event Committee Experience
The CEC has performed endpoint adjudication since 1994 with extensive experience adjudicating cardiovascular and neurologic endpoints in multi-center, international trials of diverse sizes and characteristics. Examples include SYMPHONY (6000 patients, 600 sites), RAPPORT (483 patients, 30 sites), GUSTO V (16,000 patients, 945 sites), EPILOG STENT (2399 patients, 63 sites), CONSERVE (1005 patients, 31 sites), ASIS (491 patients, 38 sites), EPILOG (2792 patients, 69 sites), CREDO (1525 patients, 119 sites), TARGET (4808 patients, 92 sites), REPLACE-2 (6000 patients, 200 sites), and CHARISMA (15,603 patients, 800 sites).

Contact:
Narcis Pasca, RN, MBA - Manager, Clinical Events Committee
(216) 444-8273
pascan @ ccf.org