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The Assessment of Patient-Reported Outcomes for the Authorisation of Medicines in Europe: A Review of European Public Assessment Reports from 2017 to 2022
OBJECTIVES: Health regulators have progressively increased their attention and focus on patient-reported outcomes (PROs), driven by the diffusion of a patient-centred approach to the drug development process. This study investigates the consideration of PROs and their measures (PROMs) in the authori...
Autores principales: | Meregaglia, Michela, Malandrini, Francesco, Angelini, Stefania, Ciani, Oriana |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10627987/ https://www.ncbi.nlm.nih.gov/pubmed/37659000 http://dx.doi.org/10.1007/s40258-023-00827-3 |
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