Biomarker-Stratified Phase III Clinical Trials: Enhancement with a Subgroup-Focused Sequential Design.

Abstract

Among various design approaches to phase III clinical trials with a predictive biomarker, the marker-stratified all-comers design is advantageous because it allows for establishing the utility of both treatment and biomarker, but it is often criticized for requiring large sample sizes, as the design includes both marker-positive and marker-negative patients… (More)
DOI: 10.1158/1078-0432.CCR-17-1552

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