2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

卷:71

Review

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.^8,9  Farb, Andrew¹⁰  Morrow, David A.⁵  Targum, Shari L.¹  Sila, Cathy A.¹¹  Hai, Mary T. Thanh¹²  Jaff, Michael R.¹³  Joffe, Hylton V.¹⁴  Cutlip, Donald E.¹⁵  Desai, Akshay S.⁷  Lewis, Eldrin F.⁷  Gibson, C. Michael¹⁶  Landray, Martin J.^17,18  White, Christopher J.¹⁹  Brooks, Steven S.²⁰  Rosenfield, Kenneth²¹  Domanski, Michael J.²²  Lansky, Alexandra J.²³  McMurray, John J. V.²⁴  Tcheng, James E.²⁵  Steinhubl, Steven R.²⁶  Burton, Paul²⁷  Mauri, Laura²⁸  O'Connor, Christopher M.²⁹  Hung, H. M. James³⁰  Stockbridge, Norman L.¹  Chaitman, Bernard R.³¹  Temple, Robert J.³² 

[1] US FDA, Div Cardiovasc & Renal Prod, Off Drug Evaluat 1, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave,Bldg 22,Room 4182, Silver Spring, MD 20993 USA

[2] Stanford Univ, Dept Med, Sch Med, Stanford Ctr Clin Res, Stanford, CA 94305 USA

[3] Icahn Sch Med Mt Sinai, Div Cardiol, New York, NY 10029 USA

[4] Cleveland Clin, Dept Cardiovasc Med, Cleveland, OH 44106 USA

[5] Brigham & Womens Hosp, Cardiovasc Div, TIMI Study Grp, 75 Francis St, Boston, MA 02115 USA

[6] US FDA, Div Neurol Prod, Off Drug Evaluat 1, Ctr Drug Evaluat & Res, Silver Spring, MD USA

[7] Brigham & Womens Hosp, Div Cardiovasc, 75 Francis St, Boston, MA 02115 USA

[8] Univ Calif San Francisco, Sect Cardiol, San Francisco Vet Affairs Med Ctr, San Francisco, CA 94143 USA

[9] Univ Calif San Francisco, Sch Med, San Francisco, CA 94143 USA

[10] US FDA, Div Cardiovasc Devices, Ctr Devices & Radiol Hlth, Silver Spring, MD USA

[11] Univ Hosp Cleveland, Med Ctr, Neurol Inst, Cleveland, OH 44106 USA

[12] US FDA, Off Drug Evaluat 2, Ctr Drug Evaluat & Res, Silver Spring, MD USA

[13] Harvard Med Sch, Dept Med, Boston, MA USA

[14] US FDA, Div Bone Reprod & Urol Prod, Off Drug Evaluat 3, Ctr Drug Evaluat & Res, Silver Spring, MD USA

[15] Harvard Med Sch, Beth Israel Deaconess Med Ctr, Dept Med, Cardiol Div, Boston, MA USA

[16] Harvard Med Sch, Dept Med, Cardiovasc Div, Boston, MA USA

[17] Univ Oxford, Clin Trial Serv Unit, Oxford, England

[18] Univ Oxford, Epidemiol Studies Unit CTSU, Oxford, England

[19] Ochsner Clin Sch, Dept Cardiol, New Orleans, LA USA

[20] Brooks Medtech LLC, Reisterstown, MD USA

[21] Massachusetts Gen Hosp, Corrigan Minehan Heart Ctr, Vasc Med & Intervent, Boston, MA 02114 USA

[22] Univ Toronto, Peter Munk Cardiac Ctr, Univ Hlth Network, Mt Sinai Hosp, Toronto, ON, Canada

[23] Yale Sch Med, Cardiol Sect, Dept Internal Med, New Haven, CT USA

[24] Univ Glasgow, Inst Cardiovasc & Med Sci, BHF Cardiovasc Res Ctr, Glasgow, Lanark, Scotland

[25] Duke Univ, Med Ctr, Div Cardiovasc Med, Durham, NC USA

[26] Scripps Translat Sci Inst, Div Digital Med, La Jolla, CA USA

[27] Janssen Pharmaceut Inc, Cardiovasc & Metab Med Affairs, Titusville, NJ USA

[28] Harvard Med Sch, Brigham & Womens Hosp, Dept Med, Cardiovasc Div, Boston, MA USA

[29] Inova Heart & Vasc Inst, Div Cardiol, Falls Church, VA USA

[30] US FDA, Ctr Drug Evaluat & Res, Off Biostat, Div Biometr 1, Silver Spring, MD USA

[31] St Louis Univ, Sch Med, Ctr Comprehens Cardiovasc Care, St Louis, MO USA

[32] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD USA

关键词: cardiovascular and stroke endpoint definitions;    cardiovascular and stroke outcome definitions;    cardiovascular and stroke outcomes;    cardiovascular endpoint definitions;    cardiovascular endpoints;    cardiovascular outcomes;    clinical trial endpoint definitions;    clinical trial endpoints;    endpoint definitions;    endpoints;    outcome definitions;    stroke endpoint definitions;    stroke endpoints;    stroke outcomes;   

DOI  :  10.1016/j.jacc.2017.12.048

来源: Elsevier

【 摘 要 】

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. Published jointly by the American College of Cardiology Foundation and American Heart Association, Inc.

【 授权许可】

Free