A Multiple Testing Procedure for Clinical Trials
1979/09/01 by Peter C. O'Brien, Peter C. O’Brien, Thomas R. Fleming · 3,370 citations
Decision Sciences · Mathematics · Medicine · #Chi-square test #Computer science #Mathematics #Medicine #Meta-analysis and systematic reviews #Multiple comparisons problem #Optimal Experimental Design Methods #Sample size determination #Statistic #Statistical Methods in Clinical Trials #Statistical hypothesis testing #Statistics #Test (biology) #Test statistic
paper · doi:10.2307/2530245
published in Biometrics 35(3), 549 (Oxford University Press)
openalex publication_date 1979/09/01 · openalex created_date 2025/10/10 · openalex updated_date 2026/08/05
Abstract
A multiple testing procedure is proposed for comparing two treatments when response to treatment is both dichotomous (i.e., success or failure) and immediate. The proposed test statistic for each test is the usual (Pearson) chi-square statistic based on all data collected to that point. The maximum number (N) of tests and the number (m1 + m2) of observations collected between successive tests is fixed in advance. The overall size of the procedure is shown to be controlled with virtually the same accuracy as the single sample chi-square test based on N(m1 + m2) observations. The power is also found to be virtually the same. However, by affording the opportunity to terminate early when one treatment performs markedly better than the other, the multiple testing procedure may eliminate the ethical dilemmas that often accompany clinical trials.
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