Article ID Journal Published Year Pages File Type
8757635 Contemporary Clinical Trials 2017 6 Pages PDF
Abstract
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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