Confirmatory seamless phase II/III clinical trials with hypotheses selection at interim: applications and practical considerations

Biom J. 2006 Aug;48(4):635-43. doi: 10.1002/bimj.200510231.

Abstract

Adaptive seamless phase II/III designs combine a phase II and a phase III study into one single confirmatory clinical trial. Several examples of such designs are presented, where the primary endpoint is binary, time-to-event or continuous. The interim adaptations considered include the selection of treatments and the selection of hypotheses related to a pre-specified subgroup of patients. Practical aspects concerning the planning and implementation of adaptive seamless confirmatory studies are also discussed.

MeSH terms

  • Clinical Trials, Phase II as Topic / statistics & numerical data*
  • Clinical Trials, Phase III as Topic / statistics & numerical data*
  • Endpoint Determination*
  • Research Design / statistics & numerical data*
  • Sample Size