Real‐world evidence to support regulatory decision‐making for medicines: Considerations for external control arms

Randomized clinical trials (RCTs) are the gold standard in producing clinical evidence of efficacy and safety of medical interventions. More recently, a new paradigm is emerging—specifically within the context of preauthorization regulatory decision‐making—for some novel uses of real‐world evidence...

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Detalles Bibliográficos
Autores principales: Burcu, Mehmet, Dreyer, Nancy A., Franklin, Jessica M., Blum, Michael D., Critchlow, Cathy W., Perfetto, Eleanor M., Zhou, Wei
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley & Sons, Inc. 2020
Materias:
Original Reports
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7687199/
https://www.ncbi.nlm.nih.gov/pubmed/32162381
http://dx.doi.org/10.1002/pds.4975

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7687199/
https://www.ncbi.nlm.nih.gov/pubmed/32162381
http://dx.doi.org/10.1002/pds.4975

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