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Nonparametric non‐inferiority analyses in the three‐arm design with active control and placebo

The three‐arm design with test treatment, reference treatment and placebo offers internal assay sensitivity for a proof of non‐inferiority. In this design the relative effects known from nonparametric theory are robust tools allowing the assessment of non‐inferiority in a range of situations. An asymptotic nonparametric theory is established in the three‐arm design based on the asymptotic distribution of rank means under alternative. A rank test for non‐inferiority is derived. Fieller's formula is used to calculate a respective confidence interval. The approach is expanded to multicentre studies. The simulation studies are conducted demonstrating the accuracy of the methods and an example is discussed. Copyright © 2009 John Wiley & Sons, Ltd.