Title | Phase II Trials for Heterogeneous Patient Populations with a Time-to-Event Endpoint. |
Publication Type | Journal Article |
Year of Publication | 2017 |
Authors | Jung, Sin-Ho |
Journal | Med Res Arch |
Volume | 5 |
Issue | 7 |
Date Published | 2017 Jul |
ISSN | 2375-1916 |
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. |
DOI | 10.18103/mra.v5i7.1377 |
Alternate Journal | Med Res Arch |
Original Publication | Phase II trials for heterogeneous patient populations with a time-to-event endpoint. |
PubMed ID | 29302620 |
PubMed Central ID | PMC5749428 |
Grant List | P01 CA142538 / CA / NCI NIH HHS / United States |
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