Clinical Events Committee

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.

Clinical Events Committee Process
An experienced, cardiovascular CEC Project Manager 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 the CEC Charter (including 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 identified through a variety of mechanisms including investigator identified events, case report form triggers, and SAEs.
 
C5Research utilizes a multi-reviewer process involving independent review by at least 2 physicians. The CEC maintains the highest standards for reviewer accuracy and consistency. This quality is assessed on an ongoing basis throughout the clinical trial.
Adjudicated Events
  • Death (all causes)
  • Myocardial infarction
  • Angina
  • Heart failure
  • Revascularization
  • Bleeding
  • Stroke (TIA)
  •  Arrhythmias
  • Resuscitated sudden death
  • Peripheral artery
  • GI
  • Hypertension
  • Renal
  • Vascular complications
  • Valvular dysfunction
  • Rashes


Clinical Event Committee Experience
The CEC has performed endpoint adjudication since 1994 with extensive experience adjudicating cardiovascular and neurologic endpoints in over 50 multi-center, international trials of diverse sizes and characteristics. We also have experience with adjudication of endpoints from other disease areas including gastroenterology and dermatology
 Trial/Program Therapy No. Subjects Publication
 45CL242/243/403 Alvimopan 480 EU 2014
 VISTA-16 Varespladib Methyl 6500 JAMA 2014
 ALECARDIO Aleglitizar 7000 JAMA 2014
 ALENEPHRO Aleglitizar 300 BMC Neph 2014
 AQUARIUS Aliskirin 592 JAMA 2013
 EXAMINE Alogliptin 5400 NEJM 2013
 LANCELOT 201/202 E5555 1200 CIRC 2011
 Lilly EIAF LY2484595 400 JAMA 2011
 CRESCENDO rimonabant 17,000 Lancet 2010
 Starlix Navigator Nateglinide/valsartan 9152 NEJM 2010
 SYNCHRONY Aleglitizar 300 Lancet 2009
 FINESSE Abciximab /reteplase 3,000 AHJ 2008
 Stradavarius Rimonabant 800 JAMA 2008
 AbeSTT I and II Abciximab 2200 STROKE 2008
 CHARISMA Clopidogrel 15,603 NEJM 2006
 CONSERVE IVT LP Stent 1005 JIC 2003
 REPLACE bivalirudin 6000 JAMA 2003
 CREDO Clopidogrel 1525 JAMA 2002
 CACHET Bivalrudin 7000 AHJ 2002
 GUSTO V IIbIIIa Inhibitor 16,000 Lancet 2001
 TARGET Tirofiban 4808 NEJM 2001
 SYMPHONY IIbIIIa Inhibitor 6000 Lancet 2000
 EPILOG STENT abciximab 2399 Lancet 1998
 EPILOG abciximab 2792 NEJM 1997