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Role of patient-reported outcomes and other efficacy endpoints in the drug approval process in Europe (2008–2012)
The present study aimed at systematically reviewing the role and extent of patient-reported outcomes (PROs) usage within the package of scientific evidence considered for marketing authorization (MA). All regulatory information published by the European Medicines Agency (EMA) for products authorized...
| Autores principales: | , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Atlantis Press
2015
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7320500/ https://www.ncbi.nlm.nih.gov/pubmed/26031612 http://dx.doi.org/10.1016/j.jegh.2015.04.006 |