Two-stage sample size re-estimation based on a nuisance parameter: a review

J Biopharm Stat. 2005;15(4):559-74. doi: 10.1081/BIP-200062852.

Abstract

Sample size calculations are important and difficult in clinical trails because they depend on the nuisance parameter and treatment effect. Recently, much attention has been focused on two-stage methods whereby the first stage constitutes an internal pilot study used to estimate parameters and revise the final sample size. This paper reviews two-stage methods based on estimation of nuisance parameters in either a continuous or dichotomous outcome setting.

MeSH terms

  • Algorithms
  • Clinical Trials as Topic / statistics & numerical data*
  • Data Interpretation, Statistical*
  • Diet
  • Humans
  • Hypertension / diet therapy
  • Pilot Projects
  • Research Design
  • Sample Size*
  • Treatment Outcome