2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials

Karen A Hicks; Kenneth W Mahaffey; Roxana Mehran; Steven E Nissen; Stephen D Wiviott; Billy Dunn; Scott D Solomon; John R Marler; John R Teerlink; Andrew Farb; David A Morrow; Shari L Targum; Cathy A Sila; Mary T Thanh Hai; Michael R Jaff; Hylton V Joffe; Donald E Cutlip; Akshay S Desai; Eldrin F Lewis; C Michael Gibson; Martin J Landray; A Michael Lincoff; Christopher J White; Steven S Brooks; Kenneth Rosenfield; Michael J Domanski; Alexandra J Lansky; John J V McMurray; James E Tcheng; Steven R Steinhubl; Paul Burton; Laura Mauri; Christopher M O'Connor; Marc A Pfeffer; H M James Hung; Norman L Stockbridge; Bernard R Chaitman; Robert J Temple; Standardized Data Collection for Cardiovascular Trials Initiative (SCTI)

doi:10.1161/CIRCULATIONAHA.117.033502

2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials

Circulation. 2018 Feb 27;137(9):961-972. doi: 10.1161/CIRCULATIONAHA.117.033502.

Authors

Karen A Hicks¹, Kenneth W Mahaffey², Roxana Mehran³, Steven E Nissen⁴, Stephen D Wiviott⁵, Billy Dunn⁶, Scott D Solomon⁷, John R Marler⁶, John R Teerlink⁸, Andrew Farb⁹, David A Morrow⁵, Shari L Targum¹⁰, Cathy A Sila¹¹, Mary T Thanh Hai¹², Michael R Jaff¹³, Hylton V Joffe¹⁴, Donald E Cutlip¹⁵, Akshay S Desai⁷, Eldrin F Lewis⁷, C Michael Gibson¹⁶, Martin J Landray¹⁷, A Michael Lincoff⁴, Christopher J White¹⁸, Steven S Brooks¹⁹, Kenneth Rosenfield²⁰, Michael J Domanski²¹, Alexandra J Lansky²², John J V McMurray²³, James E Tcheng²⁴, Steven R Steinhubl²⁵, Paul Burton²⁶, Laura Mauri²⁷, Christopher M O'Connor²⁸, Marc A Pfeffer⁷, H M James Hung²⁹, Norman L Stockbridge¹⁰, Bernard R Chaitman³⁰, Robert J Temple³¹; Standardized Data Collection for Cardiovascular Trials Initiative (SCTI)

Affiliations

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.). karen.hicks@fda.hhs.gov.
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 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.).
¹¹ Neurological Institute, University Hospitals-Cleveland Medical Center, Cleveland, Ohio (C.A.S.).
¹² 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.).
¹³ Department of Medicine, Harvard Medical School, Boston, Massachusetts (M.R.J.).
¹⁴ 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.).
¹⁵ Cardiology Division, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts (D.E.C.).
¹⁶ Cardiovascular Division, Department of Medicine, Harvard Medical School, Boston, Massachusetts (C.M.G.).
¹⁷ Clinical Trial Service Unit & Epidemiological Studies Unit (CTSU), University of Oxford, Oxford, United Kingdom (M.J.L.).
¹⁸ Department of Cardiology, Ochsner Clinical School, New Orleans, Louisiana (C.J.W.).
¹⁹ Brooks Medtech, LLC, Reisterstown, Maryland (S.S.B.).
²⁰ Vascular Medicine and Intervention, Corrigan Minehan Heart Center, Massachusetts General Hospital, Boston, Massachusetts (K.R.).
²¹ Peter Munk Cardiac Centre, University Health Network/Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada (M.J.D.).
²² Department of Internal Medicine, Section of Cardiology, Yale School of Medicine, New Haven, Connecticut (A.J.L.).
²³ Institute of Cardiovascular & Medical Sciences, BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, Scotland (J.J.V.M.).
²⁴ Division of Cardiovascular Medicine, Duke University Medical Center, Durham, North Carolina (J.E.T.).
²⁵ Division of Digital Medicine, Scripps Translational Science Institute, La Jolla, California (S.R.S.).
²⁶ Cardiovascular and Metabolism Medical Affairs, Janssen Pharmaceuticals Inc., Titusville, New Jersey (P.B.).
²⁷ Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts (L.M.).
²⁸ Division of Cardiology, Inova Heart & Vascular Institute, Falls Church, Virginia (C.M.O.).
²⁹ 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.).
³⁰ Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis, Missouri (B.R.C.).
³¹ Center for Drug Evaluation and Research (CDER), United States Food and Drug Administration (FDA), Silver Spring, Maryland (R.J.T.).

PMID: 29483172
DOI: 10.1161/CIRCULATIONAHA.117.033502

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.

Keywords: 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.

Publication types

Review

MeSH terms

Cardiovascular Diseases / diagnosis*
Clinical Trials as Topic
Data Collection / standards*
Endpoint Determination / standards*
Humans
Stroke / diagnosis*
United States
United States Food and Drug Administration