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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...
| Autores principales: | , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
John Wiley and Sons Inc.
2019
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7687110/ https://www.ncbi.nlm.nih.gov/pubmed/31823482 http://dx.doi.org/10.1002/pds.4932 |