For a variety of reasons, medications and devices specifically developed for children have traditionally lagged behind similar products for adults. A new federally funded program intends to address these unmet medical needs by improving quality and efficiency in developing innovative pediatric medicines and devices.
A pediatrician from Children's Hospital of Philadelphia (CHOP) is among the leaders of a national program currently launching a global clinical trials network, aimed at strengthening the development of innovative treatments and devices for children. To accomplish this, the network plans to incorporate best practices, novel approaches and streamlined conduct of regulatory-quality clinical trials.
The U.S. Food and Drug Administration recently awarded a cooperative agreement for $1 million in fiscal year 2017 funds with the potential for $1 million each year for an additional four years, to the Institute for Advanced Clinical Trials for Children (I-ACT for Children), contingent on annual appropriations and the availability of funding. I-ACT for Children, a new independent, nonprofit organization that works to improve the planning and completion of pediatric clinical trials, is allied with several other organizations committed to children's health--one of which is PEDSnet, a national clinical research network of eight children's hospitals, including CHOP.
"This award brings together leaders in pediatric trials innovation from across the public and private sectors in an exciting new clinical trials network, and creates an environment of continuous learning and quality improvement to ensure its sustainability," said CHOP pediatrician Christopher Forrest, MD, PhD, co-investigator of the FDA grant and the principal investigator of PEDSnet. Forrest added that the new network will focus on planning and strategy, best practices and education, and management of trials infrastructure for development of new medicines and devices.
Leading the network as principal investigator is Edward Connor, MD, MBE, president of I-ACT and an emeritus professor of Pediatrics, Microbiology, Immunology, and Tropical Medicine at George Washington University School of Medicine and Children's National Health System. Connor said, "Through this cooperative agreement we and our alliance partners will work to establish a sustainable global infrastructure for pediatric clinical trials that is collaborative, child-centered and promotes regulatory science and innovative methodologies to improve research on the safety and effectiveness of new medicines and devices for children. We are honored by FDA's confidence in our approach for a new paradigm in pediatric clinical trials."
Joining I-ACT and PEDSnet are the James M. Anderson Center for Health Systems Excellence, the Critical Path Institute and the National Capital Consortium for Pediatric Device Innovation, working together with leading children's institutions and health systems. PEDSnet and the Anderson Center will serve as the network's data and learning core, the Critical Path Institute will be the regulatory science core, and the National Capital Consortium will be the device core.
Work has been initiated to integrate network components and engage public and private shareholders in this work. Next steps include selecting priority projects for implementation in 2018 and beyond, and scaling the network in North America and abroad.
Funding for this work was made possible, in part, by the Food and Drug Administration through grant 1 U18 FD 006297. Views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.
About Children's Hospital of Philadelphia: Children's Hospital of Philadelphia was founded in 1855 as the nation's first pediatric hospital. Through its long-standing commitment to providing exceptional patient care, training new generations of pediatric healthcare professionals and pioneering major research initiatives, Children's Hospital has fostered many discoveries that have benefited children worldwide. Its pediatric research program is among the largest in the country. In addition, its unique family-centered care and public service programs have brought the 546-bed hospital recognition as a leading advocate for children and adolescents. For more information, visit http://www.