Posted by Michael Wonder on 22 Aug 2017
What should patients be told about non-inferiority studies?
21 August 2017 - A non-inferiority trial is a study in which a new treatment is compared with an existing, already available treatment, but in which the statistical analysis does not evaluate the possible superiority of the new treatment.
Rather, it tests whether the new treatment is not worse than the existing treatment, using a pre-specified threshold for the evaluation (the “non-inferiority margin”).
In the latest issue of JAMA Internal Medicine, Doshi et al. explore both what patients are being told, and what they should be told, about the purpose of the research when being asked to participate in a non-inferiority trial designed to test the comparative efficacy and safety of antibiotics.
