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

Jianrong Wu

Research output: Contribution to journalArticlepeer-review

6 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 languageEnglish
Pages (from-to)25-34
Number of pages10
JournalStatistics in Biopharmaceutical Research
Volume9
Issue number1
DOIs
StatePublished - 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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