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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...
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| Publicado no: | Pharmacoepidemiol Drug Saf |
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| Main Authors: | , , , , , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
John Wiley & Sons, Inc.
2020
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC7687199/ https://ncbi.nlm.nih.gov/pubmed/32162381 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/pds.4975 |
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