Resources dedicated to creating medicines to meet the unique needs of children have grown steadily since legislation guiding pediatric drug development was enacted in the U.S. two decades ago, and the outlook for still greater development looks promising, according to a new analysis completed by the Tufts Center for the Study of Drug Development.
Even though R&D complexity has grown more than 50% since 2008, resources dedicated to pediatric studies have increased across most R&D functions, according to the new Tufts CSDD study, which updates a similar assessment it completed nearly a decade ago.
"Much has changed since 2007, including the need to conduct pediatric studies earlier in development across all age groups, with appropriate formulations, in the context of a changing, more complex research environment," said Christopher-Paul Milne, research associate professor and director of research at Tufts CSDD at Tufts University School of Medicine, who conducted the analysis.
Since the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were enacted in 2002 and 2003, respectively, more than 600 drugs and biologicals originally developed for adults have been labeled in the U.S. with specific information to inform safer administration and dosing in children.
"Developing formulations for children was not achieved easily and remains a costly and complex undertaking," said Milne.
He noted that pediatric R&D today must account for expanded data requirements and changes imposed by advances in pharmacogenomics, regulatory science, and multi-country clinical trial networks.