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
| Trial/Program | Therapy | No. Subjects | Publication |
|---|---|---|---|
| ARMMS-T2D | Metabolic Surgery | 302 | Diabetes Obes Metab 2022 |
| RHAPSODY | Rilonacept | 61 | NEJM 2021 |
| STELLAR 3 & 4 | Selonsertib | 1,679 | J Hepatol 2020 |
| STRENGTH | EPA and DHA | 13,078 | JAMA 2020 |
| LPR | IVUS-NIRS | 1563 | Lancet 2019 |
| PARTNER 3 | TAVR | 1000 | NEJM 2019 |
| ACCLERATE | Evacetrapib | 12,092 | NEJM 2017 |
| AMG-334 Migraine | Erenumab | 483 | Lancet Neurol 2016 |
| 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 | Aleglitazar | 7000 | JAMA 2014 |
| ALENEPHRO | Aleglitazar | 300 | BMC Neph 2014 |
| AQUARIUS | Aliskiren | 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 | Aleglitazar | 300 | Lancet 2009 |
| FINESSE | Abciximab /reteplase | 3,000 | AHJ 2008 |
| STRADIVARIUS | 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 | Bivalirudin | 7000 | AHJ 2002 |
| GUSTO V | IIb/IIIa Inhibitor | 16,000 | Lancet 2001 |
| TARGET | Tirofiban | 4808 | NEJM 2001 |
| SYMPHONY | IIb/IIIa Inhibitor | 6000 | Lancet 2000 |
| EPILOG STENT | Abciximab | 2399 | Lancet 1998 |
| EPILOG |
Abciximab |
2792 | NEJM 1997 |
