An efficient multiple-stage procedure for phase II clinical trials that have high response rate objectives

Shande Chen, Soong Seng-jaw Soong, Richard H. Wheeler

Research output: Contribution to journalArticle

10 Scopus citations

Abstract

Gehan's two-stage procedure is commonly used in phase II clinical trials to enable one to stop a trial early if the observed response rate in the first stage does not warrant further study and to obtain an adequate estimate of response rate if the trial passes the first stage. However, when the response rate of interest is relatively high (0.3 or more), Gehan's procedure can be inefficient since the trial may hardly be halted even though the actual response rate is low. In this paper, we extend Gehan's two-stage procedure to a more efficient multiple-stage procedure, which allows early termination of a phase II trial at multiple stages and provides precise estimate of the response rate if the trial reaches the final stage. The proposed multiple-sstage procedure is suitable for phase II clinical trials that have high response rate objectives.

Original languageEnglish
Pages (from-to)277-283
Number of pages7
JournalControlled Clinical Trials
Volume15
Issue number4
DOIs
StatePublished - 1 Jan 1994

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Keywords

  • Gehan's two-stage procedure
  • early stopping
  • rejection error
  • sequential design

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