2017 cardiovascular and stroke endpoint definitions for clinical trials

Hicks, K. A. et al. (2018) 2017 cardiovascular and stroke endpoint definitions for clinical trials. Journal of the American College of Cardiology, 71(9), pp. 1021-1034. (doi:10.1016/j.jacc.2017.12.048) (PMID:29495982)

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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.

Item Type:Articles
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.
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:McMurray, Professor John
Authors: Hicks, K. A., Mahaffey, K. W., Mehran, R., Nissen, S. E., Wiviott, S. D., Dunn, B., Solomon, S. D., Marler, J. R., Teerlink, J. R., Farb, A., Morrow, D. A., Targum, S. L., Sila, C. A., Thanh Hai, M. T., Jaff, M. R., Joffe, H. V., Cutlip, D. E., Desai, A. S., Lewis, E. F., Gibson, C. M., Landray, M. J., Lincoff, A. M., White, C. J., Brooks, S. S., Rosenfield, K., Domanski, M. J., Lansky, A. J., McMurray, J. J.V., Tcheng, J. E., Steinhubl, S. R., Burton, P., Mauri, L., O'Connor, C. M., Pfeffer, M. A., Hung, H. M. J., Stockbridge, N. L., Chaitman, B. R., and Temple, R. J.
College/School:College of Medical Veterinary and Life Sciences > Institute of Cardiovascular and Medical Sciences
Journal Name:Journal of the American College of Cardiology
Publisher:Elsevier
ISSN:0735-1097
ISSN (Online):1558-3597
Published Online:26 February 2018

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