On sample size calculation based on odds ratio in clinical trials

J Biopharm Stat. 2002 Nov;12(4):471-83. doi: 10.1081/BIP-120016231.

Abstract

Sample size calculation formulas for testing equality, noninferiority, superiority, and equivalence based on odds ratio were derived under both parallel and one-arm crossover designs. An example concerning the study of odds ratio between a test compound (treatment) and a standard therapy (control) for prevention of relapse in subjects with schizophrenia and schizoaffective disorder is presented to illustrate the derived formulas for sample size calculation for various hypotheses under both a parallel design and a crossover design. Simulations were performed to assess the adequacy of the sample size calculation formulas. Simulation results were given at the end of the paper.

MeSH terms

  • Algorithms
  • Antipsychotic Agents / therapeutic use
  • Clinical Trials as Topic / statistics & numerical data*
  • Cross-Over Studies
  • Humans
  • Odds Ratio*
  • Psychotic Disorders / drug therapy
  • Recurrence
  • Risk Assessment
  • Sample Size*
  • Schizophrenia / drug therapy

Substances

  • Antipsychotic Agents