title: Centralized adjudication of cardiovascular end points in cardiovascular and noncardiovascular pharmacologic trials: a report from the Cardiac Safety Research Consortium.
abstract: This white paper provides a summary of presentations and discussions at a cardiovascular (CV) end point adjudication think tank cosponsored by the Cardiac Safety Research Committee and the US Food and Drug Administration (FDA) that was convened at the FDA's White Oak headquarters on November 6, 2013. Attention was focused on the lack of clarity concerning the need for end point adjudication in both CV and non-CV trials: there is currently an absence of widely accepted academic or industry standards and a definitive regulatory policy on how best to structure and use clinical end point committees (CECs). This meeting therefore provided a forum for leaders in the fields of CV clinical trials and CV safety to develop a foundation of initial best practice recommendations for use in future CEC charters. Attendees included representatives from pharmaceutical companies, regulatory agencies, end point adjudication specialist groups, clinical research organizations, and active, academically based adjudicators. The manuscript presents recommendations from the think tank regarding when CV end point adjudication should be considered in trials conducted by cardiologists and by noncardiologists as well as detailing key issues in the composition of a CEC and its charter. In addition, it presents several recommended best practices for the establishment and operation of CECs. The science underlying CV event adjudication is evolving, and suggestions for additional areas of research will be needed to continue to advance this science. This manuscript does not constitute regulatory guidance.
authors: ACI Clinical, Bala Cynwyd, PA. Electronic address: jseltzer@aciclinical.com.
authors: Jonathan H
authors: JH
authors: Seltzer
authors: Quintiles, Durham, NC.
authors: J Rick
authors: JR
authors: Turner
authors: Regeneron Pharmaceuticals, Inc, Tarrytown, NY.
authors: Mary Jane
authors: MJ
authors: Geiger
authors: Cardiovascular Working Party, European Medicines Agency, London, UK.
authors: Giuseppe
authors: G
authors: Rosano
authors: Stanford University School of Medicine, Palo Alto, CA.
authors: Kenneth W
authors: KW
authors: Mahaffey
authors: University of Connecticut School of Medicine, Farmington, CT.
authors: William B
authors: WB
authors: White
authors: GlaxoSmith Kline Pharmaceuticals Inc, Upper Providence, PA.
authors: Mary Beth
authors: MB
authors: Sabol
authors: US Food and Drug Administration, Silver Spring, MD.
authors: Norman
authors: N
authors: Stockbridge
authors: Stanford University School of Medicine, Palo Alto, CA.
authors: Philip T
authors: PT
authors: Sager
mesh_terms: D019985:Benchmarking; D002309:Cardiology / Q000379:methods / Q000592:standards; D002318:Cardiovascular Diseases / Q000188:drug therapy*; D026661:Clinical Trials Data Monitoring Committees; D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards; D023381:Endpoint Determination / Q000379:methods / Q000592:standards; D006801:Humans; D000069437:Pharmacological Phenomena; D012107:Research Design; D017751:Safety Management; D014481:United States; D014486:United States Food and Drug Administration