title: Simultaneous confidence intervals on multivariate non-inferiority.
abstract: We discuss the analysis of non-inferiority trials based on a multi-armed design with multiple correlated endpoints. We consider five different scenarios: (1) global non-inferiority; (2) non-inferiority for subsets of comparisons; (3) global non-inferiority for a treatment group; (4) global non-inferiority for an endpoint; and (5) local non-inferiority. We describe and compare related approaches, which are based on the union-intersection and intersection-union test principles - alone and in combination. Because non-inferiority thresholds for many differently scaled endpoints are rarely available in practice, the approaches described focus on the estimation of simultaneous confidence limits and their post hoc interpretation on non-inferiority. We discuss and demonstrate pros and cons by means of a real data example.
authors.affiliation: Lehrfach Variationsstatistik, Christian-Albrechts-University of Kiel, Germany. hasler@email.uni-kiel.de
authors.forename: M
authors.initials: M
authors.lastname: Hasler
authors.forename: L A
authors.initials: LA
authors.lastname: Hothorn
mesh_terms: D056808:Biostatistics; D016001:Confidence Intervals; D006801:Humans; D015233:Models, Statistical; D015999:Multivariate Analysis; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*