The Smooth Away From Expected (SAFE) non-inferiority frontier: theory and implementation with an application to the D3 trial
Abstract Background In a non-inferiority trial, the choice of margin depends on the expected control event risk. If the true risk differs from expected, power and interpretability of results can be affected. A non-inferiority frontier pre-specifies an appropriate non-inferiority margin for each valu...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
BMC
2023-08-01
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| Series: | Trials |
| Online Access: | https://doi.org/10.1186/s13063-023-07586-5 |