CRO New England Research Institutes (NERI) has secured an $18 million contract with the National Institutes of Health (NIH) to develop and test circulatory devices for children, helping to fuel more work in pediatric clinical research.
With the deal in place, NERI will help test ventricular assist devices (VADs) and extracorporeal membrane oxygenation devices (ECMOs), according to a company statement. NERI's work is one part of NIH's PumpKIN program (Pumps for Kids, Infants, and Neonates), a four-year program announced in 2010. Its goal is to fund the completion of animal studies for devices to help children born with congenital heart defects or who develop heart failure, to speed FDA approval for clinical testing, as Mass High Tech explains.
While NERI conducts clinical trials for all ages, it has focused much of its work of late in pediatrics, generating about $105 million in clinical funding. About half of its clinical trials include pediatric subjects, ranging from newborns to teenagers.
Pediatric clinical research could stand to see more development, according to regulators. Most drugs prescribed for children haven't been tested on them, and before the FDA initiated its pediatric program, only 20% of approved drugs were labeled for safe use in children, as the regulatory body's website details. The FDA believes that is likely because pharma companies question the size and profitability of the pediatric drug market, but it also is difficult to establish trials with minors, which require obtaining parental consent.
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