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Research Letter
March 17, 2015

Reporting of Noninferiority Trials in ClinicalTrials.gov and Corresponding Publications

Author Affiliations
  • 1Yale University School of Medicine, New Haven, Connecticut
  • 2Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut
  • 3National Library of Medicine, National Institutes of Health, Bethesda, Maryland
JAMA. 2015;313(11):1163-1165. doi:10.1001/jama.2015.1697

Noninferiority clinical trials are designed to determine whether an intervention is not inferior to a comparator by more than a prespecified difference, known as the noninferiority margin. Selection of an appropriate margin is fundamental to noninferiority trial validity, yet a point of frequent ambiguity.1,2 Given the increasing use of noninferiority trial designs, maintaining high standards for conduct and reporting is a priority.3,4 Publicly accessible trial registries and results databases promote transparency and accountability by requiring specification of research designs and end points and disclosure of summary results.1,5

To better understand reporting of noninferiority trials, we examined registration records and results posted on ClinicalTrials.gov, as well as their corresponding publications, for information about the noninferiority margin and statistical analyses, and determined their association with trial and journal characteristics.