Multiplicity considerations in subgroup analysis

DOI10.1002/SIM.7416MaRDI QIDQ6996049zbMATH OpenFDO

Authors Alex Dmitrienko, Brian A. Millen, Ilya Lipkovich

Publication date 16 April 2025

Published in Statistics in Medicine (Search for Journal in Brave)

Full work available at URL https://doi.org/10.1002/SIM.7416

zbMATH Keywords

clinical trialsconfirmatory subgroup analysisexploratory subgroup analysisinfluence and interaction conditionsmultiplicity adjustment

Mathematics Subject Classification ID

Applications of statistics to biology and medical sciences; meta analysis (62P10)

Cites work

• Extension of adaptive alpha allocation methods for strong control of the family-wise error rate
• Key multiplicity issues in clinical drug development
• Multiplicity considerations for subgroup analysis subject to consistency constraint
• Traditional multiplicity adjustment methods in clinical trials
• Tutorial in biostatistics: data-driven subgroup identification and analysis in clinical trials
• Tutorial on statistical considerations on subgroup analysis in confirmatory clinical trials

Cited in

(4)

• Efficient testing of the biomarker positive and negative subgroups in a biomarker-stratified trial
• Consistency-based approach to adjust for multiplicity in confirmatory subgroup analysis
• Does remdesivir lower COVID-19 mortality? A subgroup analysis of hospitalized adults receiving supplemental oxygen
• Efficiency enhancement in testing treatment efficacy across multiple populations using treatment crossover data

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