2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials

  • Karen A. Hicks
    Division of Cardiovascular and Renal Products, Office of Drug Evaluation I, Center for Drug Evaluation and Research (CDER), United States Food and Drug Administration (FDA), Silver Spring, Maryland (K.A.H., S.L.T., N.L.S.).
  • Kenneth W. Mahaffey
    Stanford Center for Clinical Research, Department of Medicine, Stanford University School of Medicine, Stanford, California (K.W.M.).
  • Roxana Mehran
    Division of Cardiology, Icahn School of Medicine at Mount Sinai, New York, New York (R.M.).
  • Steven E. Nissen
    Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio (S.E.N., A.M.L.).
  • Stephen D. Wiviott
    TIMI Study Group, Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts (S.D.W., D.A.M.).
  • Billy Dunn
    Division of Neurology Products, Office of Drug Evaluation I, Center for Drug Evaluation and Research (CDER), United States Food and Drug Administration (FDA), Silver Spring, Maryland (B.D., J.R.M.).
  • Scott D. Solomon
    Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts (S.D.S., A.S.D., E.F.L., M.A.P.).
  • John R. Marler
    Division of Neurology Products, Office of Drug Evaluation I, Center for Drug Evaluation and Research (CDER), United States Food and Drug Administration (FDA), Silver Spring, Maryland (B.D., J.R.M.).
  • John R. Teerlink
    Section of Cardiology, San Francisco Veterans Affairs Medical Center and School of Medicine, University of California San Francisco, San Francisco, California (J.R.T.).
  • Andrew Farb
    Division of Cardiovascular Devices, Center for Devices and Radiological Health (CDRH), United States Food and Drug Administration (FDA), Silver Spring, Maryland (A.F.).
  • David A. Morrow
    TIMI Study Group, Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts (S.D.W., D.A.M.).
  • Shari L. Targum
    Division of Cardiovascular and Renal Products, Office of Drug Evaluation I, Center for Drug Evaluation and Research (CDER), United States Food and Drug Administration (FDA), Silver Spring, Maryland (K.A.H., S.L.T., N.L.S.).
  • Cathy A. Sila
    Neurological Institute, University Hospitals-Cleveland Medical Center, Cleveland, Ohio (C.A.S.).
  • Mary T. Thanh Hai
    Office of Drug Evaluation II, Center for Drug Evaluation and Research (CDER), United States Food and Drug Administration (FDA), Silver Spring, Maryland (M.T.T.).
  • Michael R. Jaff
    Department of Medicine, Harvard Medical School, Boston, Massachusetts (M.R.J.).
  • Hylton V. Joffe
    Division of Bone, Reproductive and Urologic Products, Office of Drug Evaluation III, Center for Drug Evaluation and Research (CDER), United States Food and Drug Administration (FDA), Silver Spring, Maryland (H.V.J.).
  • Donald E. Cutlip
    Cardiology Division, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts (D.E.C.).
  • Akshay S. Desai
    Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts (S.D.S., A.S.D., E.F.L., M.A.P.).
  • Eldrin F. Lewis
    Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts (S.D.S., A.S.D., E.F.L., M.A.P.).
  • C. Michael Gibson
    Cardiovascular Division, Department of Medicine, Harvard Medical School, Boston, Massachusetts (C.M.G.).
  • Martin J. Landray
    Clinical Trial Service Unit & Epidemiological Studies Unit (CTSU), University of Oxford, Oxford, United Kingdom (M.J.L.).
  • A. Michael Lincoff
    Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio (S.E.N., A.M.L.).
  • Christopher J. White
    Department of Cardiology, Ochsner Clinical School, New Orleans, Louisiana (C.J.W.).
  • Steven S. Brooks
    Brooks Medtech, LLC, Reisterstown, Maryland (S.S.B.).
  • Kenneth Rosenfield
    Vascular Medicine and Intervention, Corrigan Minehan Heart Center, Massachusetts General Hospital, Boston, Massachusetts (K.R.).
  • Michael J. Domanski
    Peter Munk Cardiac Centre, University Health Network/Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada (M.J.D.).
  • Alexandra J. Lansky
    Department of Internal Medicine, Section of Cardiology, Yale School of Medicine, New Haven, Connecticut (A.J.L.).
  • John J.V. McMurray
    Institute of Cardiovascular & Medical Sciences, BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, Scotland (J.J.V.M.).
  • James E. Tcheng
    Division of Cardiovascular Medicine, Duke University Medical Center, Durham, North Carolina (J.E.T.).
  • Steven R. Steinhubl
    Division of Digital Medicine, Scripps Translational Science Institute, La Jolla, California (S.R.S.).
  • Paul Burton
    Cardiovascular and Metabolism Medical Affairs, Janssen Pharmaceuticals Inc., Titusville, New Jersey (P.B.).
  • Laura Mauri
    Cardiovascular Division, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts (L.M.).
  • Christopher M. O’Connor
    Division of Cardiology, Inova Heart & Vascular Institute, Falls Church, Virginia (C.M.O.).
  • Marc A. Pfeffer
    Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts (S.D.S., A.S.D., E.F.L., M.A.P.).
  • H.M. James Hung
    Division of Biometrics I, Office of Biostatistics, Center for Drug Evaluation and Research (CDER), United States Food and Drug Administration (FDA), Silver Spring, Maryland (H.M.J.H.).
  • Norman L. Stockbridge
    Division of Cardiovascular and Renal Products, Office of Drug Evaluation I, Center for Drug Evaluation and Research (CDER), United States Food and Drug Administration (FDA), Silver Spring, Maryland (K.A.H., S.L.T., N.L.S.).
  • Bernard R. Chaitman
    Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis, Missouri (B.R.C.).
  • Robert J. Temple
    Center for Drug Evaluation and Research (CDER), United States Food and Drug Administration (FDA), Silver Spring, Maryland (R.J.T.).

抄録

<jats:p>This publication describes uniform definitions for cardiovascular and stroke outcomes developed by the Standardized Data Collection for Cardiovascular Trials Initiative and the US Food and Drug Administration (FDA). The FDA established the Standardized Data Collection for Cardiovascular Trials Initiative in 2009 to simplify the design and conduct of clinical trials intended to support marketing applications. The writing committee recognizes that these definitions may be used in other types of clinical trials and clinical care processes where appropriate. Use of these definitions at the FDA has enhanced the ability to aggregate data within and across medical product development programs, conduct meta-analyses to evaluate cardiovascular safety, integrate data from multiple trials, and compare effectiveness of drugs and devices. Further study is needed to determine whether prospective data collection using these common definitions improves the design, conduct, and interpretability of the results of clinical trials.</jats:p>

収録刊行物

  • Circulation

    Circulation 137 (9), 961-972, 2018-02-27

    Ovid Technologies (Wolters Kluwer Health)

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