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abstractpubmed· Abstract 2015· item PMID:26700838
Design of Major Randomized Trials: Part 3 of a 4-Part Series on Statistics for Clinical Trials. 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.