Group sequential design for historical control trials using error spending functions

Jianrong Wu, Yimei Li

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

Abstract

Group sequential designs using Lan-DeMets error spending functions are proposed for historical control trials with time-to-event endpoints. Both O’Brien–Fleming and Gamma family types of sequential decision boundaries are derived based on sequential log-rank tests, which follow a Brownian motion in a transformed information time. Simulation results show that the proposed group sequential designs using historical controls preserve the overall type I error and power.

Original languageEnglish
Pages (from-to)351-363
Number of pages13
JournalJournal of Biopharmaceutical Statistics
Volume30
Issue number2
DOIs
StatePublished - Mar 3 2020

Bibliographical note

Publisher Copyright:
© 2019, © 2019 Taylor & Francis Group, LLC.

Keywords

  • Error spending function
  • decision boundaries
  • group sequential design
  • historical control
  • information time

ASJC Scopus subject areas

  • Statistics and Probability
  • Pharmacology
  • Pharmacology (medical)

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