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), Heather D Fitter, Kachikwu Illoh, Kenneth J Cavanaugh Jr, Benjamin M Scirica, Ilan Irony, Rachel E Brown Kichline, Jonathan G Levine, Anna Park, Leonard Sacks, Ana Szarfman, Ellis F Unger, Lori Ann Wachter, Bram Zuckerman, Yale Mitchel, Douglas Peddicord, Thomas Shook, Bron Kisler, Charles Jaffe, Rhonda Bartley, David L DeMets, MariJo Mencini, Cheri Janning, Steve Bai, John Lawrence, Ralph B D'Agostino Sr, Stuart J Pocock, 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), Heather D Fitter, Kachikwu Illoh, Kenneth J Cavanaugh Jr, Benjamin M Scirica, Ilan Irony, Rachel E Brown Kichline, Jonathan G Levine, Anna Park, Leonard Sacks, Ana Szarfman, Ellis F Unger, Lori Ann Wachter, Bram Zuckerman, Yale Mitchel, Douglas Peddicord, Thomas Shook, Bron Kisler, Charles Jaffe, Rhonda Bartley, David L DeMets, MariJo Mencini, Cheri Janning, Steve Bai, John Lawrence, Ralph B D'Agostino Sr, Stuart J Pocock
Abstract
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.
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.
Copyright © 2018 American College of Cardiology Foundation and American Heart Association, Inc. Published by Elsevier Inc. All rights reserved.
Source: PubMed