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image/svg+xml Jakob Voss, based on art designer at PLoS, modified by Wikipedia users Nina and Beao Closed Access logo, derived from PLoS Open Access logo. This version with transparent background. http://commons.wikimedia.org/wiki/File:Closed_Access_logo_transparent.svg Jakob Voss, based on art designer at PLoS, modified by Wikipedia users Nina and Beao Statistics in Medici...arrow_drop_down
image/svg+xml Jakob Voss, based on art designer at PLoS, modified by Wikipedia users Nina and Beao Closed Access logo, derived from PLoS Open Access logo. This version with transparent background. http://commons.wikimedia.org/wiki/File:Closed_Access_logo_transparent.svg Jakob Voss, based on art designer at PLoS, modified by Wikipedia users Nina and Beao
Statistics in Medicine
Article . 2010 . Peer-reviewed
License: Wiley Online Library User Agreement
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Sample size determination in clinical trials with multiple co‐primary binary endpoints

Authors: Takashi, Sozu; Tomoyuki, Sugimoto; Toshimitsu, Hamasaki;

Sample size determination in clinical trials with multiple co‐primary binary endpoints

Abstract

AbstractClinical trials often employ two or more primary efficacy endpoints. One of the major problems in such trials is how to determine a sample size suitable for multiple co‐primary correlated endpoints. We provide fundamental formulae for the calculation of power and sample size in order to achieve statistical significance for all the multiple primary endpoints given as binary variables. On the basis of three association measures among primary endpoints, we discuss five methods of power and sample size calculation: the asymptotic normal method with and without continuity correction, the arcsine method with and without continuity correction, and Fisher's exact method. For all five methods, the achieved sample size decreases as the value of association measure increases when the effect sizes among endpoints are approximately equal. In particular, a high positive association has a greater effect on the decrease in the sample size. On the other hand, such a relationship is not very strong when the effect sizes are different. Copyright © 2010 John Wiley & Sons, Ltd.

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Keywords

Models, Statistical, Endpoint Determination, Migraine Disorders, Binomial Distribution, Treatment Outcome, Sample Size, Odds Ratio, Humans, Monte Carlo Method, Algorithms, Randomized Controlled Trials as Topic

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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
59
Top 10%
Top 10%
Top 10%
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