Exact sample-size determination in testing non-inferiority under a simple crossover trial.
For testing the non-inferiority (or equivalence) of an experimental treatment to a standard treatment, the odds ratio (OR) of patient response rates has been recommended to measure the relative treatment efficacy. On the basis of an exact test procedure proposed elsewhere for a simple crossover design, we develop an exact sample-size calculation procedure with respect to the OR of patient response rates for a desired power of detecting non-inferiority at a given nominal type I error. We note that the sample size calculated for a desired power based on an asymptotic test procedure can be much smaller than that based on the exact test procedure under a given situation. We further discuss the advantage and disadvantage of sample-size calculation using the exact test and the asymptotic test procedures. We employ an example by studying two inhalation devices for asthmatics to illustrate the use of sample-size calculation procedure developed here.
Department of Mathematics and Statistics, College of Sciences, San Diego State University, San Diego, CA 92182-7720, USA. kjl@rohan.sdsu.edu
Kung-Jong
KJ
Lui
Kuang-Chao
KC
Chang
D000280:Administration, Inhalation; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage; D001249:Asthma / Q000188:drug therapy; D018849:Controlled Clinical Trials as Topic / Q000379:methods*; D018592:Cross-Over Studies; D003627:Data Interpretation, Statistical; D006801:Humans; D016017:Odds Ratio; D012107:Research Design; D018401:Sample Size; D013810:Therapeutic Equivalency
D018927:Anti-Asthmatic Agents