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Peer-reviewed

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 Targum, Cathy Sila, Mary Thanh Hai, Michael R. Jaff, Hylton V. Joffe, Donald E. Cutlip, Akshay S. Desai, Eldrin F. Lewis, C. Michael Gibson, Martin Landray, A. Michael Lincoff, Christopher J. White, Steven S. Brooks, Kenneth Rosenfield, Michaël 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, Hung Hung, Norman Stockbridge, Bernard Chaitman, Robert J. Temple

Circulation · 2018

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Summary

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 comp

Source type
Peer-reviewed study
DOI
10.1161/circulationaha.117.033502
Catalogue ID
SNmojg093g-9bl86y
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