Curtailed two-stage matched pairs design in double-arm Phase II clinical trials

Christa Carsten, Pinyuen Chen

Research output: Contribution to journalArticle

3 Scopus citations

Abstract

This article proposes a curtailed two-stage matched pairs design to shorten the drug development process in Phase II clinical trials for which there are two arms, a treatment arm and a control arm, and the primary goal being to test whether the treatment is significantly better than the control. The design presented in this article uses the inverse trinomial distribution to determine appropriate cutoff points for the termination or continuation of the trial at each stage and is best suited for trials in which there is a low success rate and the available sample size is limited, such as is the case for trials involving rare forms of cancer or other uncommon diseases.

Original languageEnglish (US)
Pages (from-to)816-822
Number of pages7
JournalJournal of Biopharmaceutical Statistics
Volume26
Issue number5
DOIs
StatePublished - Sep 2 2016

Keywords

  • Curtailed two-stage design
  • Phase II clinical trial
  • double-arm
  • expected sample size
  • matched pairs

ASJC Scopus subject areas

  • Statistics and Probability
  • Pharmacology
  • Pharmacology (medical)

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