2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials

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 Initi...

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Podrobná bibliografie
Vydáno v:	Circulation (New York, N.Y.) Ročník 137; číslo 9; s. 961
Hlavní autoři:	Hicks, Karen A, Mahaffey, Kenneth W, Mehran, Roxana, Nissen, Steven E, Wiviott, Stephen D, Dunn, Billy, Solomon, Scott D, Marler, John R, Teerlink, John R, Farb, Andrew, Morrow, David A, Targum, Shari L, Sila, Cathy A, Hai, Mary T Thanh, Jaff, Michael R, Joffe, Hylton V, Cutlip, Donald E, Desai, Akshay S, Lewis, Eldrin F, Gibson, C Michael, Landray, Martin J, Lincoff, A Michael, White, Christopher J, Brooks, Steven S, Rosenfield, Kenneth, Domanski, Michael J, Lansky, Alexandra J, McMurray, John J V, Tcheng, James E, Steinhubl, Steven R, Burton, Paul, Mauri, Laura, O'Connor, Christopher M, Pfeffer, Marc A, Hung, H M James, Stockbridge, Norman L, Chaitman, Bernard R, Temple, Robert J
Médium:	Journal Article
Jazyk:	angličtina
Vydáno:	United States 27.02.2018
Témata:	endpoints cardiovascular outcomes clinical trial endpoints stroke outcomes endpoint definitions cardiovascular and stroke outcome definitions outcome definitions cardiovascular endpoints stroke endpoint definitions cardiovascular and stroke endpoint definitions clinical trial endpoint definitions cardiovascular endpoint definitions cardiovascular and stroke outcomes stroke endpoints
ISSN:	1524-4539, 1524-4539
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Popis
Shrnutí:	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.
Bibliografie:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 ObjectType-Review-3 content type line 23
ISSN:	1524-4539 1524-4539
DOI:	10.1161/CIRCULATIONAHA.117.033502