Testing a Primary and a Secondary Endpoint in a Group Sequential Design

DOI10.1111/J.1541-0420.2010.01402.XMaRDI QIDQ3076047zbMATH OpenOpenAlexWikidataFDO

Authors Ajit C. Tamhane, Cyrus R. Mehta, Lingyun Liu

Publication date 17 February 2011

Published in Biometrics (Search for Journal in Brave)

Full work available at URL http://europepmc.org/articles/pmc2925065

zbMATH Keywords

powermultiple comparisonsfamilywise error ratemultiple endpointsO'Brien-Fleming boundaryPocock boundarygatekeeping proceduressecondary power

Mathematics Subject Classification ID

Applications of statistics to biology and medical sciences; meta analysis (62P10) Sequential statistical design (62L05) Sequential statistical analysis (62L10)

Recommendations

• A gatekeeping procedure to test a primary and a secondary endpoint in a group sequential design with multiple interim looks
• Design and Analysis of Group Sequential Clinical Trials with Multiple Primary Endpoints
• Improved two-stage group sequential procedures for testing a secondary endpoint after the primary endpoint achieves significance
• Testing Secondary Hypotheses Following Sequential Clinical Trials
• Two-stage group sequential designs for comparative clinical trials
• Closed Testing Procedures for Group Sequential Clinical Trials with Multiple Endpoints
• Tests and confidence intervals for secondary endpoints in sequential clinical trials

Cites work

• scientific article; zbMATH DE number 1348603 (Why is no real title available?)
• Approximately Optimal One-Parameter Boundaries for Group Sequential Trials
• Closed Testing Procedures for Group Sequential Clinical Trials with Multiple Endpoints
• Discrete Sequential Boundaries for Clinical Trials
• Group Sequential Tests for Bivariate Response: Interim Analyses of Clinical Trials with Both Efficacy and Safety Endpoints
• On closed testing procedures with special reference to ordered analysis of variance
• P Values Maximized Over a Confidence Set for the Nuisance Parameter

Cited in

(16)

• Sequential tests controlling generalized familywise error rates
• Step-up and step-down methods for testing multiple hypotheses in sequential experiments
• Design and Analysis of Group Sequential Clinical Trials with Multiple Primary Endpoints
• Allocating recycled significance levels in group sequential procedures for multiple endpoints
• Interim evaluation of efficacy or futility in group‐sequential trials with multiple co‐primary endpoints
• A Note on Familywise Error Rate for a Primary and Secondary Endpoint
• Sample size optimization and initial allocation of the significance levels in group sequential trials with multiple endpoints
• Multiple comparisons in complex clinical trial designs
• Familywise error for multiple time-to-event endpoints in a group sequential design
• An order restricted multi-arm multi-stage clinical trial design
• Group sequential Holm and Hochberg procedures
• Comparison of design strategies for a three-arm clinical trial with time-to-event endpoint: power, time-to-analysis, and operational aspects
• Refined critical boundary with enhanced statistical power for non-directional two-sided tests in group sequential designs with multiple endpoints
• Improved two-stage group sequential procedures for testing a secondary endpoint after the primary endpoint achieves significance
• Group-sequential logrank methods for trial designs using bivariate non-competing event-time outcomes
• A gatekeeping procedure to test a primary and a secondary endpoint in a group sequential design with multiple interim looks

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