A gatekeeping procedure to test a primary and a secondary endpoint in a group sequential design with multiple interim looks

DOI10.1111/biom.12732zbMath1415.62138OpenAlexW2622633411WikidataQ36394662 ScholiaQ36394662MaRDI QIDQ3119803

Teresa Curto, Christopher Jennison, Cyrus R. Mehta, Ajit C. Tamhane, Jiangtao Gou

Publication date: 13 March 2019

Published in: Biometrics (Search for Journal in Brave)

Full work available at URL: http://opus.bath.ac.uk/56489/1/Tamhane_et_al_for_Biometrics.pdf

zbMATH Keywords

familywise error ratemultiple comparisonssequential designmultiple endpointsgatekeepingO'Brien-Fleming boundaryPocock boundarysecondary powerLan-DeMets error spending function approachprimary power

Mathematics Subject Classification ID

Applications of statistics to biology and medical sciences; meta analysis (62P10) Sequential statistical design (62L05) Paired and multiple comparisons; multiple testing (62J15)

Related Items (4)

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 ⋮ Approval policies for modifications to machine learning‐based software as a medical device: A study of bio‐creep ⋮ Refined critical boundary with enhanced statistical power for non-directional two-sided tests in group sequential designs with multiple endpoints

Uses Software

• CRAN
• gsrsb

Cites Work

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• Statistical monitoring of clinical trials. A unified approach.
• Testing a Primary and a Secondary Endpoint in a Group Sequential Design
• Discrete Sequential Boundaries for Clinical Trials
• Group Sequential Tests for Bivariate Response: Interim Analyses of Clinical Trials with Both Efficacy and Safety Endpoints
• Closed Testing Procedures for Group Sequential Clinical Trials with Multiple Endpoints

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