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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...
Autores principales: | Haag, Susanne, Junge, Lisa, Lotz, Fabian, McGauran, Natalie, Paulides, Marios, Potthast, Regine, Kaiser, Thomas |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2021
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Materias: | |
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 |
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