2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials

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

Affiliated Institutions

• Brigham and Women's Hospital US
• Center for Drug Evaluation and Research US
• Comprehensive Cardiovascular US
• Harvard University US
• United States Food and Drug Administration US
• Scripps Research Institute US
• Yale University US
• Duke University Hospital US
• Thrombolysis in Myocardial Infarction Study Group US
• San Francisco VA Medical Center US
• University Health Network CA
• University of Toronto CA
• University of Oxford GB
• Icahn School of Medicine at Mount Sinai US
• Center for Devices and Radiological Health US
• Bon Secours Heart & Vascular Institute US
• Cleveland Clinic US
• Massachusetts General Hospital US
• University of Glasgow GB
• Duke Medical Center US
• Center for Clinical Research (United States) US
• Stanford University US
• Beth Israel Deaconess Medical Center US
• Ochsner Medical Center US
• Mount Sinai Hospital CA
• Janssen (United States) US
• University of California, San Francisco US

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