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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Detalles Bibliográficos
Autores principales: Baumfeld Andre, Elodie, Reynolds, Robert, Caubel, Patrick, Azoulay, Laurent, Dreyer, Nancy A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2019
Materias:
Reviews
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

Internet

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

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