Assessment of Noninferiority Margins in Cardiovascular Medicine Trials
Authors' conclusion
Recalculating noninferiority margins based on actual event rates, rather than anticipated ones, led to different outcomes in approximately 1 out of 4 cardiovascular trials, with most divergent trials lacking cautionary interpretation.
Study context
- Population
- Noninferiority trials presented at major cardiovascular conferences 2015–2022 and published in the same period48 comparisons from 45 trials analysed
- Participants
- 768 trials
- Comparison
- Absolute NI margin recalculated on observed vs anticipated control event rates
- Divergentn = 11
- Outcome
- Proportion of trials with a different interpretation after recalculation of the absolute noninferiority margin
Methodological detailsmethodological review of noninferiority trials
- Methodological review of noninferiority trials
Main finding
As reported in the abstract
Divergent results after margin recalculation
Divergent
22.9%
11
- Trials originally claiming noninferiority that did not meet it after recalculation
- 10
Further findings
Median
| Outcome | Divergent | Other trials | P value |
|---|---|---|---|
| Difference between anticipated and recalculated NI margins | 44.7% (IQR 38.6%–56.7%) | 15.3% (IQR −1.5%–28.9%) | P < 0.001 |
Cautionary interpretation in conclusions
- None of the 10 trials losing noninferiority included cautionary statements in the conclusion
Original publication
Assessment of Noninferiority Margins in Cardiovascular Medicine Trials. JACC Adv. Published 5 June 2024. doi:10.
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