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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...

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Detalles Bibliográficos
Autores principales: Quartagno, Matteo, Chan, Man, Turkova, Anna, Ford, Deborah, White, Ian R.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
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