Journal
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Volume 66, Issue 24, Pages 2757-2766Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jacc.2015.10.036
Keywords
avoidance of bias; randomized controlled trial; sample size; selection of patients; study design; treatments and endpoints
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This paper provides practical guidance on the fundamentals of design for major randomized controlled trials. Topics covered include the choice of patients, choice of treatment and control groups, choice of primary and secondary endpoints, methods of randomization, appropriate use of blinding, and determination of trial size. Insights are made with reference to contemporary major trials in cardiology. (C) 2015 by the American College of Cardiology Foundation.
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