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Invited Commentary
October 2017

What Should Patients Be Told About Noninferiority Studies?

Author Affiliations
  • 1Office for Human Research Protections, Department of Health and Human Services, Rockville, Maryland
JAMA Intern Med. 2017;177(10):1459-1460. doi:10.1001/jamainternmed.2017.3825

A noninferiority 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 prespecified threshold for the evaluation (the “noninferiority margin”). In this issue of JAMA Internal Medicine, Doshi et al1 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 noninferiority trial designed to test the comparative efficacy and safety of antibiotics.

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