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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Detalhes bibliográficos
Publicado no:Trials
Main Authors: Downing, Nicholas S., Shah, Nilay D., Neiman, Joseph H., Aminawung, Jenerius A., Krumholz, Harlan M., Ross, Joseph S.
Formato: Artigo
Idioma:Inglês
Publicado em: BioMed Central 2016
Assuntos:
Research
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC4832528/
https://ncbi.nlm.nih.gov/pubmed/27079511
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1186/s13063-016-1322-4
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