Sample size re-estimation for adaptive sequential design in clinical trials

J Biopharm Stat. 2008;18(6):1184-96. doi: 10.1080/10543400802369053.

Abstract

There is considerable interest in methods that use accumulated data to modify trial sample size. However, sample size re-estimation in group sequential designs has been controversial. We describe a method for sample size re-estimation at the penultimate stage of a group sequential design that achieves specified power against an alternative hypothesis corresponding to the current point estimate of the treatment effect.

Publication types

  • Comparative Study

MeSH terms

  • Clinical Trials as Topic / statistics & numerical data*
  • Computer Simulation
  • Data Interpretation, Statistical*
  • Humans
  • Markov Chains
  • Models, Statistical*
  • Sample Size*
  • Time Factors
  • Treatment Outcome