An approach to confirmatory testing of subpopulations in clinical trials

DOI10.1002/BIMJ.201400006MaRDI QIDQ3465347zbMATH OpenOpenAlexWikidataFDO

Authors Ekkehard Glimm, Lilla di Scala

Publication date 21 January 2016

Published in Biometrical Journal (Search for Journal in Brave)

Full work available at URL https://doi.org/10.1002/bimj.201400006

zbMATH Keywords

stratifiedmodel-basedbiomarkersubpopulationssuper-responders

Mathematics Subject Classification ID

Applications of statistics to biology and medical sciences; meta analysis (62P10) Medical applications (general) (92C50)

Recommendations

• A multiple comparison procedure for dose-finding trials with subpopulations
• Correct and logical inference on efficacy in subgroups and their mixture for binary outcomes
• Optimal tests of treatment effects for the overall population and two subpopulations in randomized trials, using sparse linear programming
• Confidence regions for treatment effects in subgroups in biomarker stratified designs
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Cites work

• scientific article; zbMATH DE number 1348603 (Why is no real title available?)
• A Multiple Comparison Procedure for Comparing Several Treatments with a Control
• A Step-Up Multiple Test Procedure
• Graphical approaches for multiple comparison procedures using weighted Bonferroni, Simes, or parametric tests
• Power gain by pre-testing?
• The two-sample \(t\) test: pre-testing its assumptions does not pay off

Cited in

(1)

• Statistical verification of PCTL using antithetic and stratified samples

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