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) www.chop.edu is working with 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 goal, the network plans to incorporate best practices, novel approaches, and streamline the conduct of regulatory quality clinical trials.
To move the program forward, FDA recently awarded a cooperative agreement for $1 million in FY 2017 funds with the potential to award $1 million each year for an additional four years. The funding went to the Institute for Advanced Clinical Trials for Children (I-ACT for Children) www.iactc.org but is contingent on annual appropriations and the availability of funding.
I-ACT for Children, a new independent nonprofit organization working to improve the planning and completion of pediatric clinical trials, is allied with several other organizations committed to children’s health. One of these organizations PEDSnet https://pedsnet.org is a national clinical research network of eight children’s hospitals including CHOP.
Edward Connor MD President of I-ACT said, “Our organization and our alliance partners will work to establish a sustainable global infrastructure for pediatric clinical trials that is collaborative, child-centered, and in the long term will promote regulatory science and innovative methodologies to improve research on the safety and effectiveness of new medicines and devices for children.”
Joining I-ACT and PEDSnet are the James M. Anderson Center for Health Systems Excellence www.cincinnatichildrens.org, the Critical Path Institute https://c-path.org, and the National Capital Consortium for Pediatric Device Innovation www.innovate4kids.org.