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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...
Autores principales: | Burcu, Mehmet, Dreyer, Nancy A., Franklin, Jessica M., Blum, Michael D., Critchlow, Cathy W., Perfetto, Eleanor M., Zhou, Wei |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley & Sons, Inc.
2020
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Materias: | |
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 |
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