Sample size recalculation in internal pilot study designs: a review

Biom J. 2006 Aug;48(4):537-55. doi: 10.1002/bimj.200510238.


The adequacy of sample size is important to clinical trials. In the planning phase of a trial, however, the investigators are often quite uncertain about the sizes of parameters which are needed for sample size calculations. A solution to this problem is mid-course recalculation of the sample size during the ongoing trial. In internal pilot study designs, nuisance parameters are estimated on the basis of interim data and the sample size is adjusted accordingly. This review attempts to give an overview on the available methods. It is written not only for biometricians who are already familar with the the topic and wish to update their knowledge but also for users new to the subject.

Publication types

  • Review

MeSH terms

  • Clinical Trials as Topic / statistics & numerical data*
  • Confidence Intervals
  • Data Interpretation, Statistical
  • Pilot Projects
  • Research Design / statistics & numerical data*
  • Sample Size