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| Pharmaceutical Statistics | | Wiley Online Library : Pharmaceutical Statistics |
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| Exact sample‐size determination in testing non‐inferiority under a simple crossover trial |
| 10 Jan 2012, 07:01:35 | Kung‐Jong LuiKuang‐Chao Chang |
| 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. |
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