title: Nonparametric non-inferiority analyses in the three-arm design with active control and placebo.
abstract: 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.
authors.affiliation: MEDA Pharma GmbH & Co KG, Benzstr. 1, 61352 Bad Homburg, Germany. ullrich.munzel@medapharma.de
authors.forename: Ullrich
authors.initials: U
authors.lastname: Munzel
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D003198:Computer Simulation; D003929:Diabetic Neuropathies / Q000188:drug therapy; D006801:Humans; D015337:Multicenter Studies as Topic / Q000379:methods*; D010146:Pain / Q000517:prevention & control; D018709:Statistics, Nonparametric; D013810:Therapeutic Equivalency; D008063:Thioctic Acid / Q000008:administration & dosage / Q000627:therapeutic use
chemical_list: D008063:Thioctic Acid