Interim evaluation of efficacy or futility in group‐sequential trials with multiple co‐primary endpoints

DOI10.1002/BIMJ.201600026MaRDI QIDQ5280188zbMATH OpenOpenAlexWikidataFDO

Authors Koko Asakura, Toshimitsu Hamasaki, Scott R. Evans

Publication date 20 July 2017

Published in Biometrical Journal (Search for Journal in Brave)

Full work available at URL http://europepmc.org/articles/pmc6222168

zbMATH Keywords

futilitygroup sequential designmultiple endpointserror-spending methodnonbinding boundarytype I and type II error adjustments

Mathematics Subject Classification ID

Applications of statistics to biology and medical sciences; meta analysis (62P10) Optimal statistical designs (62K05) Sequential statistical analysis (62L10)

Recommendations

• Group-Sequential Clinical Trials with Multiple Co-Objectives
• Design and Analysis of Group Sequential Clinical Trials with Multiple Primary Endpoints
• Interim and terminal analyses of clinical trials with failure-time endpoints and related group sequential designs
• Evaluating co-primary endpoints collectively in clinical trials
• A New Interim Monitoring Statistic for Group Sequential Clinical Trials
• Interim analyses with repeated measurements in a sequential clinical trial
• A gatekeeping procedure to test a primary and a secondary endpoint in a group sequential design with multiple interim looks

Cites work

• scientific article; zbMATH DE number 67146 (Why is no real title available?)
• scientific article; zbMATH DE number 1348603 (Why is no real title available?)
• Closed Testing Procedures for Group Sequential Clinical Trials with Multiple Endpoints
• Design and Analysis of Group Sequential Clinical Trials with Multiple Primary Endpoints
• Discrete Sequential Boundaries for Clinical Trials
• Group Sequential Tests for Bivariate Response: Interim Analyses of Clinical Trials with Both Efficacy and Safety Endpoints
• Group-Sequential Clinical Trials with Multiple Co-Objectives
• Guidelines for Monitoring Efficacy and Toxicity Responses in Clinical Trials
• Sample size determination in clinical trials with multiple endpoints
• Stochastically curtailed tests in long–term clinical trials
• Symmetric Group Sequential Test Designs
• Testing a Primary and a Secondary Endpoint in a Group Sequential Design

Cited in

(8)

• Adaptive group-sequential design with population enrichment in phase 3 randomized controlled trials with two binary co-primary endpoints
• A new approach for sizing trials with composite binary endpoints using anticipated marginal values and accounting for the correlation between components
• Group-Sequential Clinical Trials with Multiple Co-Objectives
• Group sequential designs for clinical trials with bivariate endpoints
• Group sequential two-stage preference designs
• Evaluating co-primary endpoints collectively in clinical trials
• Sample size determination in clinical trials with multiple co-primary endpoints including mixed continuous and binary variables
• Simultaneous population enrichment and endpoint selection in phase 3 randomized controlled trials: An adaptive group sequential design with two binary alternative primary endpoints

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Uses Software

• QSIMVN

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