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Group sequential designs for phase II trials with historical controls.

M N Chang·J J Shuster·J L Kepner
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Abstract

Two-step tests based on historical control data are proposed for detecting different means when experimental and control populations are normally distributed with possibly different known variances. The results readily extend to the case where the control and experimental data are dichotomous. Provisions for early acceptance and early rejection are included.

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Analysis of VarianceClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicData Interpretation, StatisticalHumansNormal DistributionReproducibility of ResultsRetrospective StudiesJournal ArticleResearch Support, U.S. Gov't, P.H.S.

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BibTeXRIS

M N Chang, J J Shuster, J L Kepner. 1999. Group sequential designs for phase II trials with historical controls.. https://doi.org/10.1016/s0197-2456(99)00008-2

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