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Comparison of published core outcome sets with outcomes recommended in regulatory guidance from the US Food and Drug Administration and European Medicines Agency: cross sectional analysis
OBJECTIVE: To compare the outcomes in published core outcome sets with the outcomes recommended in corresponding guidance documents from the European Medicines Agency (EMA) and US Food and Drug Administration (FDA), matched by health condition. DESIGN: Cross sectional analysis. SETTING: US and Europ...
Autores principales: | Saldanha, Ian J, Dodd, Susanna, Fish, Rebecca, Gorst, Sarah L, Hall, Deborah A, Jacobsen, Pamela, Kirkham, Jamie J, Trepel, Dominic, Williamson, Paula R |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9978677/ https://www.ncbi.nlm.nih.gov/pubmed/36936602 http://dx.doi.org/10.1136/bmjmed-2022-000233 |
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