National Healthcare Quality and Disparities Report
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AHRQ Research Studies
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Research Studies is a compilation of published research articles funded by AHRQ or authored by AHRQ researchers.
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1 to 1 of 1 Research Studies DisplayedHwang TJ, Kesselheim AS, Bourgeois FT
Postmarketing trials and pediatric device approvals.
The authors sought to describe the current state of trial evidence underpinning the approval of pediatric devices. They found that most high-risk pediatric devices are approved on the basis of trials in patients 18 years of age or older, with few pediatric patients exposed to the devices before market availability. Also, few postmarketing studies require additional study in pediatric patients.
AHRQ-funded; HS018465.
Citation: Hwang TJ, Kesselheim AS, Bourgeois FT .
Postmarketing trials and pediatric device approvals.
Pediatrics 2014 May;133(5):e1197-202. doi: 10.1542/peds.2013-3348.
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Keywords: Children/Adolescents, Medical Devices, Patient Safety, Children/Adolescents