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2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials.
Hicks, Karen A; Mahaffey, Kenneth W; Mehran, Roxana; Nissen, Steven E; Wiviott, Stephen D; Dunn, Billy; Solomon, Scott D; Marler, John R; Teerlink, John R; Farb, Andrew; Morrow, David A; Targum, Shari L; Sila, Cathy A; Thanh Hai, Mary T; Jaff, Michael R; Joffe, Hylton V; Cutlip, Donald E; Desai, Akshay S; Lewis, Eldrin F; Gibson, C Michael; Landray, Martin J; Lincoff, A Michael; White, Christopher J; Brooks, Steven S; Rosenfield, Kenneth; Domanski, Michael J; Lansky, Alexandra J; McMurray, John J V; Tcheng, James E; Steinhubl, Steven R; Burton, Paul; Mauri, Laura; O'Connor, Christopher M; Pfeffer, Marc A; Hung, H M James; Stockbridge, Norman L; Chaitman, Bernard R; Temple, Robert J.
Afiliación
  • Hicks KA; 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. Electronic address: karen.hicks@fda.hhs.gov.
  • Mahaffey KW; Stanford Center for Clinical Research, Department of Medicine, Stanford University School of Medicine, Stanford, California.
  • Mehran R; Division of Cardiology, Icahn School of Medicine at Mount Sinai, New York, New York.
  • Nissen SE; Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.
  • Wiviott SD; TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.
  • Dunn B; 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.
  • Solomon SD; Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.
  • Marler JR; 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.
  • Teerlink JR; Section of Cardiology, San Francisco Veterans Affairs Medical Center and School of Medicine, University of California San Francisco, San Francisco, California.
  • Farb A; Division of Cardiovascular Devices, Center for Devices and Radiological Health (CDRH), United States Food and Drug Administration (FDA), Silver Spring, Maryland.
  • Morrow DA; TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.
  • Targum SL; 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.
  • Sila CA; Neurological Institute, University Hospitals-Cleveland Medical Center, Cleveland, Ohio.
  • Thanh Hai MT; Office of Drug Evaluation II, Center for Drug Evaluation and Research (CDER), United States Food and Drug Administration (FDA), Silver Spring, Maryland.
  • Jaff MR; Department of Medicine, Harvard Medical School, Boston, Massachusetts.
  • Joffe HV; 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.
  • Cutlip DE; Cardiology Division, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
  • Desai AS; Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.
  • Lewis EF; Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.
  • Gibson CM; Cardiovascular Division, Department of Medicine, Harvard Medical School, Boston, Massachusetts.
  • Landray MJ; Clinical Trial Service Unit & Epidemiological Studies Unit (CTSU), University of Oxford, Oxford, United Kingdom.
  • Lincoff AM; Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.
  • White CJ; Department of Cardiology, Ochsner Clinical School, New Orleans, Louisiana.
  • Brooks SS; Brooks Medtech, LLC, Reisterstown, Maryland.
  • Rosenfield K; Vascular Medicine and Intervention, Corrigan Minehan Heart Center, Massachusetts General Hospital, Boston, Massachusetts.
  • Domanski MJ; Peter Munk Cardiac Centre, University Health Network/Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.
  • Lansky AJ; Department of Internal Medicine, Section of Cardiology, Yale School of Medicine, New Haven, Connecticut.
  • McMurray JJV; Institute of Cardiovascular & Medical Sciences, BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, Scotland.
  • Tcheng JE; Division of Cardiovascular Medicine, Duke University Medical Center, Durham, North Carolina.
  • Steinhubl SR; Division of Digital Medicine, Scripps Translational Science Institute, La Jolla, California.
  • Burton P; Cardiovascular and Metabolism Medical Affairs, Janssen Pharmaceuticals Inc., Titusville, New Jersey.
  • Mauri L; Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
  • O'Connor CM; Division of Cardiology, Inova Heart & Vascular Institute, Falls Church, Virginia.
  • Pfeffer MA; Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.
  • Hung HMJ; Division of Biometrics I, Office of Biostatistics, Center for Drug Evaluation and Research (CDER), United States Food and Drug Administration (FDA), Silver Spring, Maryland.
  • Stockbridge NL; 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.
  • Chaitman BR; Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis, Missouri.
  • Temple RJ; Center for Drug Evaluation and Research (CDER), United States Food and Drug Administration (FDA), Silver Spring, Maryland.
J Am Coll Cardiol ; 71(9): 1021-1034, 2018 03 06.
Article en En | MEDLINE | ID: mdl-29495982
This publication describes uniform definitions for cardiovascular and stroke outcomes developed by the Standardized Data Collection for Cardiovascular Trials Initiative and the U.S. 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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Enfermedades Cardiovasculares / Ensayos Clínicos como Asunto / Accidente Cerebrovascular / Determinación de Punto Final Tipo de estudio: Etiology_studies / Observational_studies / Risk_factors_studies Límite: Humans Idioma: En Revista: J Am Coll Cardiol Año: 2018 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Enfermedades Cardiovasculares / Ensayos Clínicos como Asunto / Accidente Cerebrovascular / Determinación de Punto Final Tipo de estudio: Etiology_studies / Observational_studies / Risk_factors_studies Límite: Humans Idioma: En Revista: J Am Coll Cardiol Año: 2018 Tipo del documento: Article Pais de publicación: Estados Unidos