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Updated: Aug 7, 2025

Selecting Multiple Biomarker Subsets with Similarly Effective Binary Classification Performances
Published on: October 11, 2018
Step-down multiple testing procedures for the overall population and partitioning subgroups
1Office of Biostatistics, US Food and Drug Administration, Silver Spring, Maryland,USA.
Abstract:
Multiple comparisons procedures are described for two-armed studies where there is a primary hypothesis and one or more ordered secondary hypotheses in the scenario where the objective is to test for an effect on the overall population and/or nonoverlapping subgroups that partition the population. This scenario arises when the subgroups are defined by disease etiology or by other patient characteristics such as genetic factors, age, sex, or race, and the treatment may have differential effects in the subgroups. The procedures described control the family-wise error rate in the strong sense at a specified level α.
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