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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Bibliographische Detailangaben
Veröffentlicht in:Trials
Hauptverfasser: Downing, Nicholas S., Shah, Nilay D., Neiman, Joseph H., Aminawung, Jenerius A., Krumholz, Harlan M., Ross, Joseph S.
Format: Artigo
Sprache:Inglês
Veröffentlicht: BioMed Central 2016
Schlagworte:
Research
Online Zugang: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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