Testing and estimation in flexible group sequential designs with adaptive treatment selection

Stat Med. 2005 Dec 30;24(24):3697-714. doi: 10.1002/sim.2389.

Abstract

Integrating selection and confirmation phases into a single trial can expedite the development of new treatments and allows to use all accumulated data in the decision process. In this paper we review adaptive treatment selection based on combination tests and propose overall adjusted p-values and simultaneous confidence intervals. Also point estimation in adaptive trials is considered. The methodology is illustrated in a detailed example based on an actual planned study.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Austria
  • Clinical Trials as Topic*
  • Confidence Intervals
  • Humans
  • Models, Statistical
  • Research Design*
  • Therapies, Investigational / statistics & numerical data*