On sample size calculation based on odds ratio in clinical trials.

Journal Article (Journal Article)

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.

Full Text

Duke Authors

Cited Authors

  • Wang, H; Chow, S-C; Li, G

Published Date

  • November 2002

Published In

Volume / Issue

  • 12 / 4

Start / End Page

  • 471 - 483

PubMed ID

  • 12477070

International Standard Serial Number (ISSN)

  • 1054-3406

Digital Object Identifier (DOI)

  • 10.1081/BIP-120016231


  • eng

Conference Location

  • England