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Non-inferiority versus superiority drug claims: the (not so) subtle distinction

BACKGROUND: Current regulatory guidance and practice of non-inferiority trials are asymmetric in favor of the test treatment (Test) over the reference treatment (Control). These trials are designed to compare the relative efficacy of Test to Control by reference to a clinically important margin, M....

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Detalles Bibliográficos
Autores principales: Ganju, Jitendra, Rom, Dror
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5472861/
https://www.ncbi.nlm.nih.gov/pubmed/28619049
http://dx.doi.org/10.1186/s13063-017-2024-2