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Participation of the elderly, women, and minorities in pivotal trials supporting 2011–2013 U.S. Food and Drug Administration approvals

BACKGROUND: Pivotal trials, the clinical studies that inform U.S. Food and Drug Administration (FDA) approval decisions, provide the foundational evidence supporting the safety and efficacy of novel therapeutics. We determined the representation of the elderly, women, and patients from racial and et...

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Detalles Bibliográficos
Autores principales:	Downing, Nicholas S., Shah, Nilay D., Neiman, Joseph H., Aminawung, Jenerius A., Krumholz, Harlan M., Ross, Joseph S.
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	BioMed Central 2016
Materias:	Research
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4832528/ https://www.ncbi.nlm.nih.gov/pubmed/27079511 http://dx.doi.org/10.1186/s13063-016-1322-4

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