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Nonparametric Methods in Crossover Trials
Authors:John hrvik
Abstract:The crossover design is often used in biomedical trials since it eliminates between subject variability. This paper is concerned with the statistical analysis of data arising from such trials when assumptions like normality do not necessarily apply. Nonparametric analysis of the two-period, two-treatment design was first described by Koch in a paper 1972. The purpose of this paper is to study nonparametric methods in crossover designs with three or more treatments and an equal number of periods. The proposed test for direct treatment effects is based on within subject comparisons after removing a possible period effect. With only two treatments this test reduces to the twosided Wilcoxon signed rank test. By simulation experiments the validity of the significance level of the test when using the asymptotic distribution of the test statistic are manifested and the power against different alternatives illustrated. A test for first order carryover effects can be constructed by a straightforward generalization of the test proposed by Koch in 1972. However, since this test is based on between subject comparisons its power will be low. Our recommendation is to consider the crossover design rather than the parallel group design if the carryover effects are assumed to be neglible or positive and smaller then the direct treatment effects.
Keywords:Aligned ranks  Asymptotic relative efficiency  Crossover study  Rank tests  Williams design  Visual analog scale
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