A publication list is available here. Highlights of our current research include →
Pediatric postmarketing studies
Many medicines prescribed to children have not been studied or formally approved for pediatric use and the FDA relies on postmarketing studies to generate pediatric labeling data. Our study, published in JAMA Pediatrics, examined 222 required pediatric postmarketing studies and found that only 34% of studies were actually completed. As a result, 59% of drugs continued to lack pediatric prescribing information after a median of 7 years since market approval.
Impact of Europe's pediatric regulation
In this collaboration with the European Medicines Agency, we are studying the completion and impact of pediatric studies conducted under the EU's Pediatric Regulation, which entered into force in 2007. The first study from this project, published in PLOS Medicine, analyzed the completion and results of 326 pediatric clinical trials. Our second study, published in Lancet Child and Adolescent Health, examined the availability of pediatric information for new medicines approved by the EMA from 2010-2014.
Discontinuation of pediatric studies
Trial discontinuation and nonpublication represent potential waste in research resources and lead to compromises in medical evidence. Our paper in Pediatrics found that both discontinuation and nonpublication of pediatric studies were common, with thousands of children exposed to interventions that did not lead to published findings.
Pediatric medical devices
Although medical devices can be lifesaving for a variety of diseases, few devices have been developed specifically for children. Our study in Pediatrics examined all devices approved for use in pediatric populations since 2007 to characterize the evidence underpinning pediatric device approvals.