A Bayesian-frequentist two-stage single-arm phase II clinical trial design

Gaohong Dong, Weichung Joe Shih, Dirk Moore, Hui Quan, Stephen Marcella

Research output: Contribution to journalArticle

10 Scopus citations

Abstract

It is well-known that both frequentist and Bayesian clinical trial designs have their own advantages and disadvantages. To have better properties inherited from these two types of designs, we developed a Bayesian-frequentist two-stage single-arm phase II clinical trial design. This design allows both early acceptance and rejection of the null hypothesis (H0). The measures (for example probability of trial early termination, expected sample size, etc.) of the design properties under both frequentist and Bayesian settings are derived. Moreover, under the Bayesian setting, the upper and lower boundaries are determined with predictive probability of trial success outcome. Given a beta prior and a sample size for stage I, based on the marginal distribution of the responses at stage I, we derived Bayesian Type I and Type II error rates. By controlling both frequentist and Bayesian error rates, the Bayesian-frequentist two-stage design has special features compared with other two-stage designs.

Original languageEnglish (US)
Pages (from-to)2055-2067
Number of pages13
JournalStatistics in Medicine
Volume31
Issue number19
DOIs
StatePublished - Aug 30 2012

All Science Journal Classification (ASJC) codes

  • Epidemiology
  • Statistics and Probability

Keywords

  • Bayesian Type I and Type II error rates
  • Expected sample size
  • Frequentist Type I and Type II error rates
  • Predictive probability
  • Probability of early termination

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