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The use of randomisation-based efficacy estimators in non-inferiority trials

BACKGROUND: In a non-inferiority (NI) trial, analysis based on the intention-to-treat (ITT) principle is anti-conservative, so current guidelines recommend analysing on a per-protocol (PP) population in addition. However, PP analysis relies on the often implausible assumption of no confounders. Rand...

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Detalles Bibliográficos
Autores principales: Gillespie, David, Farewell, Daniel, Barrett-Lee, Peter, Casbard, Angela, Hawthorne, Anthony Barney, Hurt, Chris, Murray, Nick, Probert, Chris, Stenson, Rachel, Hood, Kerenza
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5343391/
https://www.ncbi.nlm.nih.gov/pubmed/28274254
http://dx.doi.org/10.1186/s13063-017-1837-3