Use of surrogate outcomes in US FDA drug approvals, 2003–2012: a survey

OBJECTIVE: To evaluate, across a spectrum of diseases, how often surrogate outcomes are used as a basis for drug approvals by the US Food and Drug Administration (FDA), and whether and how the rationale for using treatment effects on surrogates as predictors of treatment effects on patient-centred o...

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Detalles Bibliográficos
Autores principales: Yu, Tsung, Hsu, Yea-Jen, Fain, Kevin M, Boyd, Cynthia M, Holbrook, Janet T, Puhan, Milo A
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2015
Materias:
Epidemiology
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4663404/
https://www.ncbi.nlm.nih.gov/pubmed/26614616
http://dx.doi.org/10.1136/bmjopen-2015-007960

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4663404/
https://www.ncbi.nlm.nih.gov/pubmed/26614616
http://dx.doi.org/10.1136/bmjopen-2015-007960

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