title: ['Non-inferiority' trials. Tips for the critical reader. Research methodology 3].
abstract: The aim of non-inferiority trials is to show that a new treatment is not less effective than standard treatment, in other words 'non-inferior'. The non-inferiority margin should be determined before a study commences. This margin determines the maximal magnitude of difference in effectiveness permissible if it is to be concluded that a new treatment is not less effective than the standard treatment. There is usually a good reason for a non-inferiority design. For example, because the new treatment is easier to use, provides better cost-effectiveness or has fewer side effects. The reader of a non-inferiority trial should consider a number of aspects critically: (a) the reason for use of this study design, (b) the assumed benefit of the new treatment, (c) the rationale for the choice of non-inferiority margin and (d) the choice of the standard therapy with which the new treatment is compared.
authors.affiliation: Leids Universitair Medisch Centrum, afd. Klinische epidemiologie, Leiden, the Netherlands.
authors.forename: Darius
authors.initials: D
authors.lastname: Soonawala
authors.forename: Olaf M
authors.initials: OM
authors.lastname: Dekkers
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods* / Q000706:statistics & numerical data*; D004341:Drug Evaluation; D006801:Humans; D015233:Models, Statistical; D012107:Research Design