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Trial designs using real‐world data: The changing landscape of the regulatory approval process
PURPOSE: There is a need to develop hybrid trial methodology combining the best parts of traditional randomized controlled trials (RCTs) and observational study designs to produce real‐world evidence (RWE) that provides adequate scientific evidence for regulatory decision‐making. METHODS: This revie...
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| Publicado no: | Pharmacoepidemiol Drug Saf |
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| Main Authors: | , , , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
John Wiley and Sons Inc.
2019
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC7687110/ https://ncbi.nlm.nih.gov/pubmed/31823482 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/pds.4932 |
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