Sample sizes for clinical trials with normal data

Stat Med. 2004 Jun 30;23(12):1921-86. doi: 10.1002/sim.1783.


This article gives an overview of sample size calculations for parallel group and cross-over studies with Normal data. Sample size derivation is given for trials where the objective is to demonstrate: superiority, equivalence, non-inferiority, bioequivalence and estimation to a given precision, for different types I and II errors. It is demonstrated how the different trial objectives influence the null and alternative hypotheses of the trials and how these hypotheses influence the calculations. Sample size tables for the different types of trials and worked examples are given.

Publication types

  • Review

MeSH terms

  • Biometry / methods*
  • Cross-Over Studies
  • Humans
  • Randomized Controlled Trials as Topic / methods*
  • Research Design
  • Sample Size
  • Therapeutic Equivalency