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Methodological quality of oncology noninferiority clinical trials
Cole Wayant1, Andrew Ross2, Matt Vassar2
1Oklahoma State University Center for Health Sciences, Department of Biomedical Sciences, 1111 W 17th Street, Tulsa, OK, 74107, United States.
Introduction:
Noninferiority trials can show that new treatments with slightly less efficacy are safer, cheaper, or easier to administer. However, the conclusions of noninferiority trials depend on robust methodology.
Methods:
We conducted a 6 year cross-sectional investigation of the methodological quality of oncology noninferiority trials published in the top 10 oncology journals. Four key quality criteria were investigated.
Results:
Nonefficacy benefits of the new treatment were stated in 88/110 (80.0 %) trials. Justification for the noninferiority margin was provided in 79/110 (71.8 %) trials. Authors most often used previous data as justification for the chosen margin (n = 42). In 15 noninferiority trials the percent preserved effect could be calculated and the median effect preserved was 56.8 %.
Conclusions:
The oncology noninferiority trials included in our study had key methodological shortcomings, counterbalanced by a clear delineation of expected nonefficacy benefits of the new treatment.
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