Pediatric Trials Network studies lead to medication label changes
Tue, 01/15/2019 – 16:05
The Pediatric Trials Network (PTN), housed within the Duke Clinical Research Institute, has had a significant role in mediating medication label changes to include dosing, safety, and efficacy information specifically for infants and children. This data historically has been elusive because of difficulty in predicting dose response, questions about long-term health and development outcomes, and ethical quandaries. The PTN, however, creates an enriched academic environment and infrastructure where researchers, thought leaders, and trial operations collaborate to develop meaningful clinical drug trials for children. The data generated by these projects helps regulators update drug labels for pediatric application, in line with the goals of the Best Pharmaceuticals for Children Act. Of 21 medical drugs and devices submitted to FDA for label changes, eight have been approved—most recently, for lisinopril and meropenem—and three others are expected to be sanctioned this year for ampicillin, clindamycin, and acyclovir. Meanwhile, eight clinical trials are currently underway.
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Source: Pharmacy Today | www.pharmacist.com