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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...
| Autores principales: | , , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
BMJ Publishing Group
2015
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| Materias: | |
| 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 |