The Present and Future
State-of-the-Art Review
Design of Major Randomized Trials: Part 3 of a 4-Part Series on Statistics for Clinical Trials

https://doi.org/10.1016/j.jacc.2015.10.036Get rights and content
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Abstract

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.

Key Words

avoidance of bias
randomized controlled trial
sample size
selection of patients
study design
treatments and endpoints

Abbreviations and Acronyms

ACS
acute coronary syndrome
CV
cardiovascular
MI
myocardial infarction
PCI
percutaneous coronary intervention
STEMI
ST-segment elevation myocardial infarction

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The authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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