title: Directional multivariate tests rejecting null and negative effects in all variables.
abstract: This paper suggests two directional multivariate tests that aim at establishing superiority of a treatment over a control in at least one of several endpoints that are assumed to have a multivariate normal distribution. One of these tests is a one-sided, scale-invariant version of the classical Hotelling T²-test. The other is based on a summary score with weights derived from the data. Both tests overcome an important shortcoming of previous "one-sided" multivariate suggestions, namely that the null hypothesis was restricted to a single point in the multidimensional parameter space. The derivation of the tests is supplemented by simulations investigating their performance and by the application in an osteoporosis trial.
authors.affiliation: Novartis Pharma AG, Basel, Switzerland. ekkehard.Glimm@Novartis.com
authors.forename: Ekkehard
authors.initials: E
authors.lastname: Glimm
authors.forename: Jürgen
authors.initials: J
authors.lastname: Läuter
mesh_terms: D017322:Clinical Trials, Phase II as Topic; D006801:Humans; D015999:Multivariate Analysis; D010024:Osteoporosis / Q000188:drug therapy; D011336:Probability; D016896:Treatment Outcome