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2017 cardiovascular and stroke endpoint definitions for clinical trials
Hicks, Karen A. Mahaffey, Kenneth W. Mehran, Roxana Nissen, Steven E. Wiviott, Stephen D. Dunn, Billy Solomon, Scott Marler, John R. Teerlink, John R. Farb, Andrew
Hicks, Karen A.
Mahaffey, Kenneth W.
Mehran, Roxana
Nissen, Steven E.
Wiviott, Stephen D.
Dunn, Billy
Solomon, Scott
Marler, John R.
Teerlink, John R.
Farb, Andrew
Author
Hicks, Karen A.
Mahaffey, Kenneth W.
Mehran, Roxana
Nissen, Steven E.
Wiviott, Stephen D.
Dunn, Billy
Solomon, Scott
Marler, John R.
Teerlink, John R.
Farb, Andrew
Morrow, David A.
Targum, Shari L.
Sila, Cathy A.
Hai, Mary T.T.
Jaff, Michael R.
Joffe, Hylton V.
Cutlip, Donal E.
Desai, Akshay S.
Lewis, Eldrin F.
Gibson, C. Michael
Landray, Martin J.
Lincoff, A. M.
White, Christopher
Brooks, Steven S.
Rosenfield, Kenneth A.
Domanski, Michael J.
Lansky, Alexandra J.
McMurray, John
Tcheng, James E.
Steinhubl, Steven R.
Burton, Paul R.
Mauri, Laura
O'Connor, Christopher M.
Pfeffer, Marc A.
Hung, James
Stockbridge, Norman L.
Chaitman, Bernard
Temple, Robert J.
Mahaffey, Kenneth W.
Mehran, Roxana
Nissen, Steven E.
Wiviott, Stephen D.
Dunn, Billy
Solomon, Scott
Marler, John R.
Teerlink, John R.
Farb, Andrew
Morrow, David A.
Targum, Shari L.
Sila, Cathy A.
Hai, Mary T.T.
Jaff, Michael R.
Joffe, Hylton V.
Cutlip, Donal E.
Desai, Akshay S.
Lewis, Eldrin F.
Gibson, C. Michael
Landray, Martin J.
Lincoff, A. M.
White, Christopher
Brooks, Steven S.
Rosenfield, Kenneth A.
Domanski, Michael J.
Lansky, Alexandra J.
McMurray, John
Tcheng, James E.
Steinhubl, Steven R.
Burton, Paul R.
Mauri, Laura
O'Connor, Christopher M.
Pfeffer, Marc A.
Hung, James
Stockbridge, Norman L.
Chaitman, Bernard
Temple, Robert J.
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
Date
2018
Type
Journal article
Journal
Circulation
Book
Volume
137
Issue
9
Page Range
961-972
Article Number
ACU Department
Collections
Relation URI
Source URL
Event URL
Open Access Status
Open access
License
File Access
Controlled