Single-Arm Phase II Survival Trial Design Under the Proportional Hazards Model

Jianrong Wu

doi:10.1080/19466315.2016.1174147

Single-Arm Phase II Survival Trial Design Under the Proportional Hazards Model

Jianrong Wu

Internal Medicine

Research output: Contribution to journal › Article › peer-review

5 Scopus citations

Abstract

For designing single-arm phase II trials with time-to-event endpoints, a sample size formula is derived for the modified one-sample log-rank test under the proportional hazards model. The derived formula enables new methods for designing trials that allow a flexible choice of the underlying survival distribution. Simulation results showed that the proposed formula provides an accurate estimation of sample size. The sample size calculation has been implemented in an R function for the purpose of trial design. Supplementary materials for this article are available online.

Original language	English
Pages (from-to)	25-34
Number of pages	10
Journal	Statistics in Biopharmaceutical Research
Volume	9
Issue number	1
DOIs	https://doi.org/10.1080/19466315.2016.1174147
State	Published - Jan 2 2017

Bibliographical note

Funding Information:
The author acknowledges two anonymous reviewers and an editor for their valuable comments that improved an earlier version of the article. The work was supported in part by the National Cancer Institute support grant P30CA021765 and ALSAC.

Publisher Copyright:
© 2017 American Statistical Association.

Keywords

Contiguous alternative
One-sample log-rank test
Proportional hazards model
Sample size
Single-arm phase II trial
Time-to-event

ASJC Scopus subject areas

Statistics and Probability
Pharmaceutical Science

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10.1080/19466315.2016.1174147

Cite this

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abstract = "For designing single-arm phase II trials with time-to-event endpoints, a sample size formula is derived for the modified one-sample log-rank test under the proportional hazards model. The derived formula enables new methods for designing trials that allow a flexible choice of the underlying survival distribution. Simulation results showed that the proposed formula provides an accurate estimation of sample size. The sample size calculation has been implemented in an R function for the purpose of trial design. Supplementary materials for this article are available online.",

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Single-Arm Phase II Survival Trial Design Under the Proportional Hazards Model

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

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