Survival trial design and monitoring using historical controls

Jianrong Wu, Xiaoping Xiong

Research output: Contribution to journalArticlepeer-review

4 Scopus citations


In this paper, we propose a multistage group sequential procedure to design survival trials using historical controls. The formula for the number of events required for historical control trial designs is derived. Furthermore, a transformed information time is proposed for trial monitoring. An example is given to illustrate the application of the proposed methods to survival trial designs using historical controls.

Original languageEnglish
Pages (from-to)405-411
Number of pages7
JournalPharmaceutical Statistics
Issue number5
StatePublished - Sep 1 2016

Bibliographical note

Funding Information:
The author acknowledges anonymous reviewers and associate editor for their valuable comments that improved an earlier version of the paper. This work was supported in part by National Cancer Institute (NCI) support grant P30CA021765 and ALSAC.

Publisher Copyright:
Copyright © 2016 John Wiley & Sons, Ltd.


  • group sequential trial design
  • historical control
  • information time
  • log-rank test
  • sample size
  • time-to-event

ASJC Scopus subject areas

  • Statistics and Probability
  • Pharmacology
  • Pharmacology (medical)


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