Overview

Overview

The CEC provides an independent, blinded determination of trial endpoints or events, a critical factor in the acceptance of trial results by regulatory authorities, academic leaders and medical communities.

Clinical Events Committee Process

Experienced CEC Project Managers, along with the CEC Director Venu Menon, MD and Associate Director Vidyasagar Kalahasti, MD, oversee each study tailoring the CEC process to study-specific needs. Our CEC Project Managers are all experienced Registered Nurses.

The CEC process includes:

  • Protocol input and/or review
  • Process development that allows for ongoing/timely adjudication
  • CEC Charter development, including endpoint definitions
  • Identifying MedDRA terms or AE terms for event identification
  • Development of training materials
  • Adjudicator training
  • Electronic Adjudication System (EAS) workflow development
  • Customized quality assurance plans per trial

The CEC has performed endpoint adjudication since 1994. Our extensive experience includes adjudicating adult and pediatric cardiovascular and neurologic events in multi-center, international, device and pharmaceutical trials of diverse sizes and characteristics. Event types include:

  • Death
  • Cardiac ischemia
  • Heart Failure
  • Coronary and Peripheral Revascularization
  • Valvular Dysfunction
  • Bleeding 
  • Vascular Complications
  • Stroke/TIA
  • Arrhythmia/Conduction Disturbances
  • Gastrointestinal 
  • Hypertension
  • Syncope
  • Acute Kidney Injury
  • Liver Injury
  • Rash
  • Pancreatitis
  • Fractures
Clinical Events Committee Experience

Clinical Events Committee Experience

Trial/Program Therapy No. Subjects Publication
PRECISION Celecoxib 24,081 NEJM 2016
AEGIS CSL112 1,258 CIRC 2016
PARTNER 2 TAVR 2,032 NEJM 2016
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