New England Research Institutes (NERI), a privately held CRO that provides global, customized clinical trial solutions and registry services, has received an $18 million contract from the National Institutes of Health (NIH) for the PumpKIN Program for the development and clinical realization of novel pediatric circulatory support devices, such as ventricular assist devices (VADs) and extracorporeal membrane oxygenation devices (ECMOs).
The endeavor will be lead by Lynn Sleeper, ScD, and Sharon Tennstedt, PhD, and the contract signifies $105 million in total funding for pediatric clinical trials services at NERI.
Approximately 70% of medications prescribed to children have only been tested in adults. While there are FDA initiatives, such as Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA), aimed to close the gap, NERI has been working to address this imbalance for two decades, and is in the forefront of pediatric research.
NERI provides clinical trial and registry services for pediatric indications using drug or device interventions, with record growth. Approximately one-half of all NERI clinical trials include pediatric subjects encompassing over 22,000 subjects across 490 U.S. and international research sites. NERI also develops tools to educate and inform parents, clinicians, researchers and children about clinical research. In collaboration with National Heart, Lung, and Blood Institute (NHLBI), NERI developed a website, documentary film, social media presence and tools for clinics on children and clinical studies.