[Statistical notes. Randomized controlled clinical trials of both superiority and non-inferiority: critical considerations].
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.
Marubini
Ettore
E
Istituto di Statistica Medica e Biometria, Università degli Studi, Milano. ettore.marubini@unimi.it
Rebora
Paola
P
Reina
Giuseppe
G
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