title: Test non-inferiority (and equivalence) based on the odds ratio under a simple crossover trial.
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.
authors.affiliation: Department of Mathematics and Statistics, College of Sciences, San Diego State University, San Diego, CA 92182-7720, USA. kjl@rohan.sdsu.edu
authors.forename: Kung-Jong
authors.initials: KJ
authors.lastname: Lui
authors.forename: Kuang-Chao
authors.initials: KC
authors.lastname: Chang
mesh_terms: D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000627:therapeutic use; D001250:Asthma, Exercise-Induced / Q000188:drug therapy; D002648:Child; D018592:Cross-Over Studies; D003627:Data Interpretation, Statistical; D006801:Humans; D016015:Logistic Models; D016017:Odds Ratio; D018401:Sample Size; D013810:Therapeutic Equivalency
chemical_list: D018927:Anti-Asthmatic Agents