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Reporting of noninferiority trial results needs improvement
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Noninferiority trials appear to demonstrate near-complete reporting of designs and margins, but only a small proportion of these studies provide justification for choosing margins, according to researchers at Yale University.
“Our findings raise concerns about the adequacy of noninferiority trial registration and results reporting within publicly accessible trial registries and highlight the need for continued efforts to improve its quality,” the researchers wrote in JAMA.
Joseph S. Ross, MD, MHS, of Yale School of Medicine, and colleagues examined noninferiority trials posted on ClinicalTrials.gov and associated publications for information regarding noninferiority margins and statistical analyses to determine their association with trial and journal characteristics. The researchers identified 344 trials from 338 articles (six articles described more than one trial) that addressed primary results of noninferiority trials. Along with trial designs, 98.8% of the publications provided noninferiority margins. The investigators found that only 28% of the trials, however, provided any rationale for choosing those margins. The most prevalent reasons were previous research (n = 46) and reliance on expert opinion or clinical judgment (n = 43).
Conversely, on ClinicalTrials.gov, 28.8% of the trials described noninferiority designs, of which 15 (4.4% of total) provided specific noninferiority margins. Of these, nine (2.6%) were prespecified at registration. Almost all publications provided noninferiority analyses and results (n = 342; 99.4%). On ClinicalTrials.gov, 129 (37.5%) had provided summarized results, among which 76 (22.1% of total) reported that noninferiority analyses were performed and provided suitable confidence intervals or P values to assess results.
Although ClinicalTrials.gov does not specify registration data elements for describing noninferiority trial designs, it does offer specific elements for reporting noninferiority results, according to the researchers.
“Nevertheless, modifications may improve reporting and temper the possibility of post hoc distortion of design and margins, facilitating transparency and accountability for noninferiority trial conduct,” they wrote.
Disclosure: Gopal reports no relevant financial disclosures. Please see the study for a full list of all other authors’ relevant financial disclosures.
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