Design of Major Randomized Trials Part 3 of a 4-Part Series on Statistics for Clinical Trials

Stuart J. Pocock; Tim C. Clayton; Gregg W. Stone

doi:10.1016/j.jacc.2015.10.036

Design of Major Randomized Trials Part 3 of a 4-Part Series on Statistics for Clinical Trials

Stuart J. Pocock
, Tim C. Clayton
, Gregg W. Stone

Research output: Contribution to journal › Review article › peer-review

60 Scopus citations

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.

Original language	English
Pages (from-to)	2757-2766
Number of pages	10
Journal	Journal of the American College of Cardiology
Volume	66
Issue number	24
DOIs	https://doi.org/10.1016/j.jacc.2015.10.036
State	Published - 22 Dec 2015
Externally published	Yes

Keywords

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

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10.1016/j.jacc.2015.10.036

Cite this

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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.",

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AB - 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.

KW - avoidance of bias

KW - randomized controlled trial

KW - sample size

KW - selection of patients

KW - study design

KW - treatments and endpoints

UR - https://www.scopus.com/pages/publications/84955500088

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ER -

Design of Major Randomized Trials Part 3 of a 4-Part Series on Statistics for Clinical Trials

Abstract

Keywords

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Cite this