Scientific Poster Session II: Late-Breaking Original Research

Late Breaking Original Research
  Sunday, November 12, 2023
  12:45 PM–02:15 PM

Abstract

Introduction: With the abundance of novel therapies, non-inferiority (NI) trials are increasing in publication. Prior studies found inadequate quality of reporting of NI studies, but were limited to certain specialties/journals, lacked NI margin evaluation, and did not examine temporal changes in quality.

Research Question or Hypothesis: The methodological quality and reporting of NI trials has improved over time per the 2010 CONSORT NI statement.

Study Design: Systematic review

Methods: A systematic review was conducted utilizing PubMed and Cochrane Library databases. NI trials published in English in 2014 and 2019 were assessed for: study design and NI margin characteristics, primary results, and risk of bias for blinding, concealment, analysis method and missing outcome data.

Results: We included 823 studies. Between 2014 and 2019, a shift from publication in specialty to general journals (15% vs 28%, p<0.001) and from investigating pharmacological to non-pharmacological interventions (25% vs 38%, p=0.025) was observed. The NI margin was specified in most trials for both years (94% vs 95%). Rationale for the NI margin increased (36% vs 57%, p<0.001), but remained low. While clinical judgement remained the most common reason (30% vs 23%), more 2019 articles incorporated patient values (0.3% vs 21%, p<0.001). At least 50% of studies were open-label for both years. Gold standard method of analyses (both per protocol+(modified) intention to treat) declined over time [43% vs 36%, (p<0.001)].

Conclusion: The methodological quality and reporting of NI trials is inadequate but improving in some areas. Improved methods for justification of the NI margin, blinding, and analysis method are warranted to facilitate clinical decision-making.

Presenting Author

Anthony Sengul PharmD, APh
Western University of Health Sciences

Authors

Shogo Kono PharmD
West Los Angeles VA Medical Center

Michelle Kwok PharmD
Walgreen's Pharmacy

Gordon Guyatt MD
Cynthia Jackevicius BScPhm, PharmD, MSc, BCPS-AQ Cardiology, FCSHP, FAHA, FCCP
University of Toronto, Toronto, Canada

Edison Escobar PharmD
Kaiser Permanente Santa Monica

John R. Flores PharmD
Kaiser Permanente