Blinded sample size reestimation in non-inferiority trials with binary endpoints

Biom J. 2007 Dec;49(6):903-16. doi: 10.1002/bimj.200610373.


Sample size calculations in the planning of clinical trials depend on good estimates of the model parameters involved. When the estimates of these parameters have a high degree of uncertainty attached to them, it is advantageous to reestimate the sample size after an internal pilot study. For non-inferiority trials with binary outcome we compare the performance of Type I error rate and power between fixed-size designs and designs with sample size reestimation. The latter design shows itself to be effective in correcting sample size and power of the tests when misspecification of nuisance parameters occurs with the former design.

MeSH terms

  • Antihypertensive Agents / pharmacology
  • Antihypertensive Agents / therapeutic use
  • Blood Pressure / drug effects
  • Blood Pressure Monitoring, Ambulatory
  • Clinical Trials, Phase IV as Topic / methods*
  • Double-Blind Method
  • Humans
  • Hypertension / drug therapy
  • Randomized Controlled Trials as Topic / methods*
  • Research Design*
  • Sample Size*


  • Antihypertensive Agents