Design and estimation in clinical trials with subpopulation selection.

ABSTRACT: Population heterogeneity is frequently observed among patients' treatment responses in clinical trials because of various factors such as clinical background, environmental, and genetic factors. Different subpopulations defined by those baseline factors can lead to differences in the benefit or safety profile of a therapeutic intervention. Ignoring heterogeneity between subpopulations can substantially impact on medical practice. One approach to address heterogeneity necessitates designs and analysis of clinical trials with subpopulation selection. Several types of designs have been proposed for different circumstances. In this work, we discuss a class of designs that allow selection of a predefined subgroup. Using the selection based on the maximum test statistics as the worst-case scenar

SUBMITTER: Chiu YD 

PROVIDER: S-EPMC6282861 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature