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A Structured Preapproval and Postapproval Comparative Study Design Framework to Generate Valid and Transparent Real‐World Evidence for Regulatory Decisions

Real‐world evidence provides important information about the effects of medicines in routine clinical practice. To engender trust that evidence generated for regulatory purposes is sufficiently valid, transparency in the reasoning that underlies study design decisions is critical. Building on existi...

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Detalles Bibliográficos
Autores principales:	Gatto, Nicolle M., Reynolds, Robert F., Campbell, Ulka B.
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/PMC6771466/ https://www.ncbi.nlm.nih.gov/pubmed/31025311 http://dx.doi.org/10.1002/cpt.1480

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