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- W3010230260 abstract "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.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.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 %.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." @default.
- W3010230260 created "2020-03-13" @default.
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- W3010230260 date "2020-05-01" @default.
- W3010230260 modified "2023-10-16" @default.
- W3010230260 title "Methodological quality of oncology noninferiority clinical trials" @default.
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- W3010230260 doi "https://doi.org/10.1016/j.critrevonc.2020.102938" @default.
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