Results on patient-reported outcomes are underreported in summaries of product characteristics for new drugs

BACKGROUND: Summaries of product characteristics (SmPCs) are regulatory documents published upon drug approval. They should report all relevant study data and advise how to use drugs safely and effectively. Patient-reported outcomes (PROs) are increasingly used in clinical trials to incorporate the...

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Detalles Bibliográficos
Autores principales: Haag, Susanne, Junge, Lisa, Lotz, Fabian, McGauran, Natalie, Paulides, Marios, Potthast, Regine, Kaiser, Thomas
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2021
Materias:
Short Report
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8651888/
https://www.ncbi.nlm.nih.gov/pubmed/34874524
http://dx.doi.org/10.1186/s41687-021-00402-1

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8651888/
https://www.ncbi.nlm.nih.gov/pubmed/34874524
http://dx.doi.org/10.1186/s41687-021-00402-1

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