Exact sample-size determination in testing non-inferiority under a simple crossover trial.

Department of Mathematics and Statistics, College of Sciences, San Diego State University, San Diego, CA 92182-7720, USA. kjl@rohan.sdsu.edu

Pharmaceutical statistics 2012 Mar-Apr

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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. Copyright © 2012 John Wiley & Sons, Ltd.

Citation

Kung-Jong Lui, Kuang-Chao Chang. Exact sample-size determination in testing non-inferiority under a simple crossover trial. Pharmaceutical statistics. 2012 Mar-Apr;11(2):129-34