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Uncontrolled Extensions of Clinical Trials and the Use of External Controls—Scoping Opportunities and Methods

Increased interest in real‐world evidence (RWE) for clinical and regulatory decision making and the need to evaluate long‐term benefits and risks of pharmaceutical products raise the importance of understanding the use of external controls (ECs) for uncontrolled extensions of randomized controlled t...

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Detalles Bibliográficos
Autores principales:	Wang, Ching‐Yu, Berlin, Jesse A., Gertz, Barry, Davis, Kourtney, Li, Jie, Dreyer, Nancy A., Zhou, Wei, Seeger, John D., Santanello, Nancy, Winterstein, Almut G.
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	John Wiley and Sons Inc. 2021
Materias:	Research
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9290853/ https://www.ncbi.nlm.nih.gov/pubmed/34165790 http://dx.doi.org/10.1002/cpt.2346

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