Power and sample size computations in simultaneous tests for non-inferiority based on relative margins

Stat Med. 2006 Apr 15;25(7):1131-47. doi: 10.1002/sim.2359.


In this paper, we address the problem of calculating power and sample sizes associated with simultaneous tests for non-inferiority. We consider the case of comparing several experimental treatments with an active control. The approach is based on the ratio view, where the common non-inferiority margin is chosen to be some percentage of the mean of the control treatment. Two power definitions in multiple hypothesis testing, namely, complete power and minimal power, are used in the computations. The sample sizes associated with the ratio-based inference are also compared with that of a comparable inference based on the difference of means for various scenarios. It is found that the sample size required for ratio-based inferences is smaller than that of difference-based inferences when the relative non-inferiority margin is less than one and when large response values indicate better treatment effects. The results are illustrated with examples.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Data Interpretation, Statistical
  • Drug Evaluation / methods*
  • Humans
  • Models, Statistical*
  • Randomized Controlled Trials as Topic / methods*
  • Research Design
  • Sample Size*