Test non-inferiority (and equivalence) based on the odds ratio under a simple crossover trial
Article first published online: 12 JAN 2011
Copyright © 2011 John Wiley & Sons, Ltd.
Statistics in Medicine
Volume 30, Issue 11, pages 1230–1242, 20 May 2011
How to Cite
Lui, K.-J. and Chang, K.-C. (2011), Test non-inferiority (and equivalence) based on the odds ratio under a simple crossover trial. Statist. Med., 30: 1230–1242. doi: 10.1002/sim.4166
- Issue published online: 2 MAY 2011
- Article first published online: 12 JAN 2011
- Manuscript Accepted: 12 NOV 2010
- Manuscript Received: 21 MAR 2010
- binary data;
- crossover trial;
- interval estimation;
- odds ratio
For testing the non-inferiority (or equivalence) of a generic drug to a standard drug, the odds ratio (OR) of patient response rates has been recommended to measure the relative treatment efficacy. On the basis of a random effects logistic regression model, we develop asymptotic test procedures for testing non-inferiority and equivalence with respect to the OR of patient response rates under a simple crossover design. We further derive exact test procedures, which are especially useful for the situations in which the number of patients in a crossover trial is small. We address sample size calculation for testing non-inferiority and equivalence based on the asymptotic test procedures proposed here. We also discuss estimation of the OR of patient response rates for both the treatment and period effects. Finally, we include two examples, one comparing two solution aerosols in treating asthma, and the other one studying two inhalation devices for asthmatics, to illustrate the use of the proposed test procedures and estimators. Copyright © 2011 John Wiley & Sons, Ltd.