title: [Statistical notes. Randomized controlled clinical trials of both superiority and non-inferiority: critical considerations].
abstract: The aim of this statistical note, the fourth in the series, is to describe and critically appraise the randomized controlled clinical trial (RCCT) GUSTO V, which combined in a single RCCT both the superiority and non-inferiority hypotheses. In this note we present the logical path that the authors have presumably followed in planning a RCCT of such a kind. The results are reported and possible critical aspects are highlighted and debated upon. Finally the cardiologist reader is stimulated to give his own opinion on this kind of approach.
authors: Istituto di Statistica Medica e Biometria, Università degli Studi, Milano. ettore.marubini@unimi.it
authors: Ettore
authors: E
authors: Marubini
authors: Paola
authors: P
authors: Rebora
authors: Giuseppe
authors: G
authors: Reina
mesh_terms: D000465:Algorithms; D003627:Data Interpretation, Statistical; D006801:Humans; D007558:Italy; D008432:Mathematical Computing; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data; D012107:Research Design