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The Smooth Away From Expected (SAFE) non-inferiority frontier: theory and implementation with an application to the D3 trial
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 value of con...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10464088/ https://www.ncbi.nlm.nih.gov/pubmed/37626423 http://dx.doi.org/10.1186/s13063-023-07586-5 |