Single-arm phase II trial design under parametric cure models

Jianrong Wu

doi:10.1002/pst.1678

Single-arm phase II trial design under parametric cure models

Jianrong Wu

Internal Medicine

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

4 Scopus citations

Abstract

The current practice of designing single-arm phase II survival trials is limited under the exponential model. Trial design under the exponential model may not be appropriate when a portion of patients are cured. There is no literature available for designing single-arm phase II trials under the parametric cure model. In this paper, a test statistic is proposed, and a sample size formula is derived for designing single-arm phase II trials under a class of parametric cure models. Extensive simulations showed that the proposed test and sample size formula perform very well under different scenarios.

Original language	English
Pages (from-to)	226-232
Number of pages	7
Journal	Pharmaceutical Statistics
Volume	14
Issue number	3
DOIs	https://doi.org/10.1002/pst.1678
State	Published - May 1 2015

Bibliographical note

Publisher Copyright:
Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

Funding

Funders	Funder number
National Childhood Cancer Registry – National Cancer Institute	P30CA021765

Keywords

clinical trial design
cure model
sample size
single-arm phase II trial
time-to-event

ASJC Scopus subject areas

Statistics and Probability
Pharmacology
Pharmacology (medical)

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10.1002/pst.1678

Cite this

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KW - time-to-event

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Single-arm phase II trial design under parametric cure models

Abstract

Bibliographical note

Funding

Keywords

ASJC Scopus subject areas

Access to Document

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