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Home  >  Medical Research Archives  >  Issue 149  > Phase II Trials for Heterogeneous Patient Populations with a Time-to-Event Endpoint
Published in the Medical Research Archives
Jul 2017 Issue

Phase II Trials for Heterogeneous Patient Populations with a Time-to-Event Endpoint

Published on Jul 15, 2017

DOI 

Abstract

 

In this paper, we consider a single-arm phase II trial with a time-to-event end-point. We assume that the study population has multiple subpopulations with different prognosis, but the study treatment is expected to be similarly efficacious across the subpopulations. We review a stratified one-sample log-rank test and present its sample size calculation method under some practical design settings. Our sample size method requires specification of the prevalence of subpopulations. We observe that the power of the resulting sample size is not very sensitive to misspecification of the prevalence.

Author info

Sin-ho Jung

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