Get access
Advertisement

Test non-inferiority (and equivalence) based on the odds ratio under a simple crossover trial

Authors

  • Kung-Jong Lui,

    Corresponding author
    1. Department of Mathematics and Statistics, College of Sciences, San Diego State University, San Diego, CA 92182-7720, U.S.A.
    • Department of Mathematics and Statistics, College of Sciences, San Diego State University, San Diego, CA 92182-7720, U.S.A.
    Search for more papers by this author
  • Kuang-Chao Chang

    1. Department of Statistics and Information Science, Fu-Jen Catholic University, Taipei, Taiwan, Republic of China
    Search for more papers by this author

Abstract

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.

Get access to the full text of this article

Ancillary