Single-Arm Phase II Group Sequential Trial Design With Survival Endpoint at a Fixed Time Point

Jianrong Wu, Xiaoping Xiong

Research output: Contribution to journalArticlepeer-review

2 Scopus citations


In this article, three nonparametric test statistics are proposed to design single-arm phase II group sequential trials for monitoring survival probability. The small-sample properties of these test statistics are studied through simulations. Sample size formulas are derived for the fixed sample test. The Brownian motion property of the test statistics allowed us to develop a flexible group sequential design using a sequential conditional probability ratio test procedure. An example is given to illustrate the trial design by using the proposed method.

Original languageEnglish
Pages (from-to)289-301
Number of pages13
JournalStatistics in Biopharmaceutical Research
Issue number4
StatePublished - Oct 2 2014

Bibliographical note

Funding Information:
The work was supported in part by National Cancer Institute (NCI) support grant CA21765 and the American Lebanese Syrian Associated Charities (ALSAC).

Publisher Copyright:
© 2014, © American Statistical Association Statistics in Biopharmaceutical Research.


  • Brownian motion
  • Interim analysis
  • Nelson–Aalen estimate
  • Sample size
  • Single-arm phase II trial
  • Survival probability

ASJC Scopus subject areas

  • Statistics and Probability
  • Pharmaceutical Science


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