Group Sequential Design for Randomized Phase III Trials under the Weibull Model

Jianrong Wu, Xiaoping Xiong

Research output: Contribution to journalArticlepeer-review

2 Scopus citations

Abstract

In this article, a parametric sequential test is proposed under the Weibull model. The proposed test is asymptotically normal with an independent increment structure. The sample size for a fixed sample test is derived for the purpose of group sequential trial design. In addition, a multi-stage group sequential procedure is given under the Weibull model by applying the Brownian motion property of the test statistic and sequential conditional probability ratio test methodology.

Original languageEnglish
Pages (from-to)1190-1205
Number of pages16
JournalJournal of Biopharmaceutical Statistics
Volume25
Issue number6
DOIs
StatePublished - Nov 2 2015

Bibliographical note

Publisher Copyright:
Copyright © 2015 Taylor & Francis Group, LLC.

Keywords

  • Brownian motion
  • Group sequential trial
  • Randomized clinical trial
  • Sample size
  • Time-to-event
  • Weibull distribution

ASJC Scopus subject areas

  • Statistics and Probability
  • Pharmacology
  • Pharmacology (medical)

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