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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Dettagli Bibliografici
Pubblicato in:Trials
Autori principali: Downing, Nicholas S., Shah, Nilay D., Neiman, Joseph H., Aminawung, Jenerius A., Krumholz, Harlan M., Ross, Joseph S.
Natura: Artigo
Lingua:Inglês
Pubblicazione: BioMed Central 2016
Soggetti:
Research
Accesso online: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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