Details

Autor(en) / Beteiligte

• 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.
• Thanh Hai, Mary T.
• 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.
• Fitter, Heather D.
• Illoh, Kachikwu
• Cavanaugh, Kenneth J.
• Scirica, Benjamin M.
• Irony, Ilan
• Brown Kichline, Rachel E.
• Levine, Jonathan G.
• Park, Anna
• Sacks, Leonard
• Szarfman, Ana
• Unger, Ellis F.
• Wachter, Lori Ann
• Zuckerman, Bram
• Mitchel, Yale
• Peddicord, Douglas
• Shook, Thomas
• Kisler, Bron
• Jaffe, Charles
• Bartley, Rhonda
• DeMets, David L.
• Mencini, MariJo
• Janning, Cheri
• Bai, Steve
• Lawrence, John
• D’Agostino, Ralph B.
• Pocock, Stuart J.

Titel

2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials

Ist Teil von

• Journal of the American College of Cardiology, 2018-03, Vol.71 (9), p.1021-1034

Ort / Verlag

United States: Elsevier Inc

Erscheinungsjahr

2018

Quelle

MEDLINE

Beschreibungen/Notizen

• 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. [Display omitted]