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

Producción científica: Article › revisión exhaustiva

9 Citas (Scopus)

Resumen

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.

Idioma original	English
Páginas (desde-hasta)	25-34
Número de páginas	10
Publicación	Statistics in Biopharmaceutical Research
Volumen	9
N.º	1
DOI	https://doi.org/10.1080/19466315.2016.1174147
Estado	Published - ene 2 2017

Nota bibliográfica

Publisher Copyright:
© 2017 American Statistical Association.

Financiación

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.

Financiadores	Número del financiador
National Childhood Cancer Registry – National Cancer Institute	P30CA021765
American Lebanese Syrian Associated Charities

ASJC Scopus subject areas

Statistics and Probability
Pharmaceutical Science

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

Resumen

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ASJC Scopus subject areas

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