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• W2079658111 abstract "Adaptive population enrichment designs enable the data-driven selection of one or more pre-specified subpopulations in an interim analysis, and the confirmatory proof of efficacy in the selected subset at the end of the trial. Sample size reassessment and other adaptive design changes can be performed as well. Strong control of the experimentwise Type I error rate is guaranteed by use of the combination testing principle together with the closed testing argument. In this paper the general methodology and designing issues when planning such a design are reviewed. It is shown how to derive overall confidence intervals and p-values. Criteria for assessing the operating characteristics of these designs are given, and the application is illustrated by examples." @default.
• W2079658111 created "2016-06-24" @default.
• W2079658111 creator A5020211243 @default.
• W2079658111 creator A5062252458 @default.
• W2079658111 date "2014-06-06" @default.
• W2079658111 modified "2023-09-24" @default.
• W2079658111 title "Designing Issues in Confirmatory Adaptive Population Enrichment Trials" @default.
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• W2079658111 doi "https://doi.org/10.1080/10543406.2014.920869" @default.
• W2079658111 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/24905739" @default.
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