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

7 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

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

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KW - Time-to-event

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

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

Access to Document

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