Practical guidelines for adaptive seamless phase II/III clinical trials that use Bayesian methods

Peter K. Kimani, Ekkehard Glimm, Willi Maurer, Jane L. Hutton, Nigel Stallard

Research output: Contribution to journalArticlepeer-review

7 Citations (Scopus)


Hommel (Biometrical Journal; 45:581-589) proposed a flexible testing procedure for seamless phase II/III clinical trials. Schmidli et al. (Statistics in Medicine; 26:4925-4938), Kimani et al. (Statistics in Medicine; 28:917-936) and Brannath et al. (Statistics in Medicine; 28:1445-1463) exploited the flexible testing of Hommel to propose adaptation in seamless phase II/III clinical trials that incorporate prior knowledge by using Bayesian methods. In this paper, we show that adaptation incorporating prior knowledge may lead to higher power. Other important issues to consider in such adaptive designs are the gain in power (or saving in patients) over traditional testing and how utility values used to make the adaptation may be used to stop a trial early. In contrast to the aforementioned authors, we discuss these issues in detail and propose a unified approach to address them so that implementing the aforementioned designs and proposing similar designs is clearer.

Original languageEnglish
Pages (from-to)2068-2085
Number of pages18
JournalStatistics in Medicine
Issue number19
Publication statusPublished - 30 Aug 2012
Externally publishedYes


  • Conditional power
  • Power
  • Predictive utility
  • Seamless phase II/III clinical trials
  • Separate programme


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