期刊
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
卷 71, 期 9, 页码 1021-1034出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jacc.2017.12.048
关键词
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
资金
- Afferent
- Amgen
- Apple Inc.
- AstraZeneca
- Cardiva Medical Inc.
- Daiichi
- Ferring
- Google (Verily)
- Johnson Johnson
- Luitpold
- Medtronic
- Merck
- Novartis
- Sanofi
- St. Jude
- Tenax
- Eli Lilly/Daiichi-Sankyo
- Bristol-Myers Squibb
- Medicines Company
- OrbusNeich
- Bayer
- CSL Behring
- Abbott Laboratories
- Watermark Research Partners
- Novartis Pharmaceuticals
- AUM Cardiovascular, Inc.
- Beth Israel Deaconess Medical Center
- Abbvie
- Cerenis
- Eli Lilly
- Esperion
- Pfizer
- Orexigen
- Arena
- Eisai
- Aegerion
- Angelmed
- Janssen
- Xoma
- ICON Clinical
- Boston Clinical Research Institute
- Boehringer Ingelheim
- Alnylam
- Bellerophon
- Celladon
- Gilead
- GlaxoSmithKline
- Ionis Pharmaceutics
- Lone Star Heart
- Mesoblast
- MyoKardia
- National Institutes of Health/National Heart, Lung, and Blood Institute
- Sanofi Pasteur
- Theracos
- Celyad
- Cytokinetics
- Trevena
- Daiichi-Sankyo
- Roche Diagnostics
- Boston Scientific
- CeloNova
- Abbott/St. Jude Medical
- Relypsa
- Cheetah Medical
- CSL
- Abiomed
- AUM Cardiovascular
- Ablative Solutions
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. Published jointly by the American College of Cardiology Foundation and American Heart Association, Inc.
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