Clinical events classification (CEC) in clinical trials: Report on the current landscape and future directions - proceedings from the CEC Summit 2018.

Journal: American heart journal
Published Date:

Abstract

IMPORTANCE: Clinical events adjudication is pivotal for generating consistent and comparable evidence in clinical trials. The methodology of event adjudication is evolving, but research is needed to develop best practices and spur innovation.

Authors

  • Abhinav Sharma
    Department of Biological Sciences and Bioengineering (BSBE), IIT, Kanpur, India.
  • Kenneth W Mahaffey
    Stanford Center for Clinical Research, Stanford University School of Medicine, Stanford, CA.
  • Charles Michael Gibson
    Harvard Medical School, Boston, MA.
  • Karen A Hicks
    Division of Cardiology and Nephrology, Office of Cardiology, Hematology, Endocrinology, and Nephrology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD.
  • Karen P Alexander
    Department of Medicine (Cardiology), Duke University Medical Center, Durham, North Carolina, USA.
  • Maria Ali
    George Clinical, Raleigh, NC.
  • Bernard R Chaitman
    Saint Louis University School of Medicine, St. Louis, MO.
  • Claes Held
    Department of Medical Sciences, Uppsala University, Uppsala, Sweden.
  • Mark Hlatky
    Department of Health Research and Policy, Stanford University School of Medicine, Stanford, CA.
  • WIlliam Schuyler Jones
    Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.
  • Roxana Mehran
    Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY.
  • Venu Menon
    Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH.
  • Frank W Rockhold
    Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.
  • Jonathan Seltzer
    ACI Clinical, Cardiac Safety Research Consortium, Bala Cynwyd, PA.
  • Ernest Spitzer
    Cardialysis, Rotterdam, The Netherlands; Cardiology Department, Thoraxcenter, Erasmus University Medical Center, Rotterdam, The Netherlands.
  • Matthew Wilson
    GB Electronics (UK) Ltd., Worthing, United Kingdom.
  • Renato D Lopes
    Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC. Electronic address: renato.lopes@duke.edu.