2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials-Reference-Cited by-同舟云学术

2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials

Published:2018-02-27 Issue:9 Volume:137 Page:961-972
ISSN:0009-7322
Container-title:Circulation
language:en
Short-container-title:Circulation

Author:

Hicks Karen A.¹,Mahaffey Kenneth W.²,Mehran Roxana³,Nissen Steven E.⁴,Wiviott Stephen D.⁵,Dunn Billy⁶,Solomon Scott D.⁷,Marler John R.⁶,Teerlink John R.⁸,Farb Andrew⁹,Morrow David A.⁵,Targum Shari L.¹,Sila Cathy A.¹⁰,Hai Mary T. Thanh¹¹,Jaff Michael R.¹²,Joffe Hylton V.¹³,Cutlip Donald E.¹⁴,Desai Akshay S.⁷,Lewis Eldrin F.⁷,Gibson C. Michael¹⁵,Landray Martin J.¹⁶,Lincoff A. Michael⁴,White Christopher J.¹⁷,Brooks Steven S.¹⁸,Rosenfield Kenneth¹⁹,Domanski Michael J.²⁰,Lansky Alexandra J.²¹,McMurray John J.V.²²,Tcheng James E.²³,Steinhubl Steven R.²⁴,Burton Paul²⁵,Mauri Laura²⁶,O’Connor Christopher M.²⁷,Pfeffer Marc A.⁷,Hung H.M. James²⁸,Stockbridge Norman L.¹,Chaitman Bernard R.²⁹,Temple Robert J.³⁰

Affiliation:

1. 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.).

2. Stanford Center for Clinical Research, Department of Medicine, Stanford University School of Medicine, Stanford, California (K.W.M.).

3. Division of Cardiology, Icahn School of Medicine at Mount Sinai, New York, New York (R.M.).

4. Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio (S.E.N., A.M.L.).

5. TIMI Study Group, Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts (S.D.W., D.A.M.).

6. 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.).

7. Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts (S.D.S., A.S.D., E.F.L., M.A.P.).

8. Section of Cardiology, San Francisco Veterans Affairs Medical Center and School of Medicine, University of California San Francisco, San Francisco, California (J.R.T.).

9. Division of Cardiovascular Devices, Center for Devices and Radiological Health (CDRH), United States Food and Drug Administration (FDA), Silver Spring, Maryland (A.F.).

10. Neurological Institute, University Hospitals-Cleveland Medical Center, Cleveland, Ohio (C.A.S.).

11. 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.).

12. Department of Medicine, Harvard Medical School, Boston, Massachusetts (M.R.J.).

13. 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.).

14. Cardiology Division, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts (D.E.C.).

15. Cardiovascular Division, Department of Medicine, Harvard Medical School, Boston, Massachusetts (C.M.G.).

16. Clinical Trial Service Unit & Epidemiological Studies Unit (CTSU), University of Oxford, Oxford, United Kingdom (M.J.L.).

17. Department of Cardiology, Ochsner Clinical School, New Orleans, Louisiana (C.J.W.).

18. Brooks Medtech, LLC, Reisterstown, Maryland (S.S.B.).

19. Vascular Medicine and Intervention, Corrigan Minehan Heart Center, Massachusetts General Hospital, Boston, Massachusetts (K.R.).

20. Peter Munk Cardiac Centre, University Health Network/Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada (M.J.D.).

21. Department of Internal Medicine, Section of Cardiology, Yale School of Medicine, New Haven, Connecticut (A.J.L.).

22. Institute of Cardiovascular & Medical Sciences, BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, Scotland (J.J.V.M.).

23. Division of Cardiovascular Medicine, Duke University Medical Center, Durham, North Carolina (J.E.T.).

24. Division of Digital Medicine, Scripps Translational Science Institute, La Jolla, California (S.R.S.).

25. Cardiovascular and Metabolism Medical Affairs, Janssen Pharmaceuticals Inc., Titusville, New Jersey (P.B.).

26. Cardiovascular Division, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts (L.M.).

27. Division of Cardiology, Inova Heart & Vascular Institute, Falls Church, Virginia (C.M.O.).

28. 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.).

29. Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis, Missouri (B.R.C.).

30. Center for Drug Evaluation and Research (CDER), United States Food and Drug Administration (FDA), Silver Spring, Maryland (R.J.T.).

Abstract

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.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Physiology (medical),Cardiology and Cardiovascular Medicine

Link

https://www.ahajournals.org/doi/pdf/10.1161/CIRCULATIONAHA.117.033502

Reference30 articles.

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