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

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Sin-Ho Jung


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.

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How to Cite
JUNG, Sin-Ho. Phase II Trials for Heterogeneous Patient Populations with a Time-to-Event Endpoint. Medical Research Archives, [S.l.], v. 5, n. 7, july 2017. ISSN 2375-1924. Available at: <>. Date accessed: 13 july 2024.
Censoring, prevalence, sample size formula, historical control, stratified 1-sample log-rank test
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