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The application of group sequential stopping boundaries to evaluate the treatment effect of an experimental agent across a range of biomarker expression

The application of group sequential stopping boundaries to evaluate the treatment effect of an experimental agent across a range of biomarker expression

Contemporary Clinical Trials 63: 13-18

Using stopping boundaries developed for group sequential trials, we control the overall type 1 error for a series of tests that evaluate the treatment effect of an experimental agent in each of several predefined marker subgroups. We then go on to present a procedure based on these group sequential stopping boundaries that provides strong control of type 1 error for testing a series of hypothesis regarding the treatment effect over a range of marker expression. Finally this use of group sequential procedures to control the type 1 error in biomarker subset testing will be compared with some other benchmark procedures in a simulation.

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Accession: 060326393

Download citation: RISBibTeXText

PMID: 28245996

DOI: 10.1016/j.cct.2017.02.006

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