Seventy percent (70%) of medications prescribed to children have only been tested in adults. Children are not little 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, for the past two decades, New England Research Institutes, Inc (NERI) has been working to address this imbalance, and is in the forefront of pediatric research.
Today NERI announced that it 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), with Lynn Sleeper, ScD and Sharon Tennstedt, PhD as lead investigators. This swells total funding for pediatric clinical trials services at NERI to $105 million.
Beyond providing these important clinical trial and registry services, NERI is developing tools to educate and inform parents, clinicians, researchers and children about clinical research. , In collaboration with NIH, 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”. These activities garnered three prestigious Telly Awards, including a Silver in education – the highest award. These dissemination efforts aim to dispel myths, fears and misconceptions about trial participation. Over the past five years, NERI has won several top industry awards in medical education for our web based documentary film and campaign to educate parents and children about clinical trials. “Our concern is that parents make informed decisions about clinical trials for their child, not decisions based on fears and misinformation.” said Lisa Marceau, NERI’s Vice President, Media and Communications.
NERI continues to provide 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 US and international research sites. Our pediatric populations include newborns, neonates, infants, toddlers, children, adolescents, and young adults.
NERI has substantial expertise in pediatric clinical studies and translational research with support from NIH and FDA, as well as collaboration from industry. “As the need for pediatric clinical trials continues to increase, NERI is positioned to assist the pharmaceutical, biotechnology, and medical device industries meet regulatory obligations outlined in recent pediatric legislation and fill this critical knowledge gap.” said Sandra Siami, NERI’s Director, Clinical Research & Regulatory Affairs.
NERI has built its reputation on challenging populations such as pediatrics, the elderly, and rare or orphan diseases such as Marfan Syndrome, Sickle Cell Anemia, Thalessemia, and Pulmonary Hypertension. With its proven track record, NERI is uniquely positioned to help clients meet the challenges of product development and testing in the pediatric population.
NERI is a privately held CRO that provides global, customized clinical trial solutions and registry services to pharmaceutical, biotechnology, biomaterial and medical device companies. NERI has notable experience collaborating on federally-funded research with organizations like the National Institutes of Health (NIH). Since its founding in 1986, NERI has earned widespread recognition for its scientific credibility, efficiency and expertise in conducting clinical trials in numerous therapeutic areas.