[Equivalence studies in cardiovascular diseases].
An increasing number of equivalence and non-inferiority trials appeared in recent years among randomized clinical trials, particularly for the evaluation of efficacy of treatments in cardiovascular medicine. These studies are characterized by remarkable methodological issues and important ethical implications. The aim of this review was to underscore some topic methodological problems: setting the equivalence boundary, the special logic used to establish equivalence, and the determinants of sample size. A Medline search was performed in order to identify the main problems in study design and in the interpretation of results of the equivalence and non-inferiority trials in cardiovascular diseases.
Barbieri
Pietro
P
Istituto di Statistica Medica e Biometria, Università degli Studi, Milano. pietro.barbieri@fastwebnet.it
Marubini
Ettore
E
D002318:Cardiovascular Diseases / Q000188:drug therapy*; D002986:Clinical Trials as Topic; D006801:Humans; D013810:Therapeutic Equivalency