According to the report, while R&D complexity has grown more than 50% since 2008, resources dedicated to pediatric studies have also increased across most R&D functions.
Christopher-Paul Milne, research associate professor and director of research at Tufts CSDD at Tufts University School of Medicine, who conducted the analysis, explained a lot has changed over the years as the research environment has become more complex.
Specifically, he said there is a need to conduct pediatric studies earlier in development across all age groups with appropriate formulations.
Since the legislation as originally passed in 2002 and 2003, more than 600 drugs and biologicals originally developed for adults have been labeled in the US for administration and dosing in children.
However, Milne stressed that developing formulations for children remains “a costly and complex undertaking,” and must now account for expanded data requirements and advances in pharmacogenomics, regulatory science, and multi-country clinical trial networks.
According to Tufts, one of the key findings of the report was that pediatric regulatory science holds the most promise for improving pediatric drug development reliability, even though patient recruitment problems continue.
As with all clinical trials, patient recruitment and retention and modifications to study plans after study start, are also the top factors driving up development costs in pediatric trials.
However, the report said the drug development environment for pediatric rare diseases continues to move "in the right direction," although including neonates in routine drug development will remain difficult.
The report comes as good news after a recent study conducted by researchers at Boston Children's Hospital found that many pediatric trials go unfinished or unpublished.
As Outsourcing-Pharma.com previously reported, the researchers found that in all, 19% of the 599 trials in the study were discontinued early, and 30% of completed trials remained unpublished in medical literature several years later.
Senior investigator Florence Bourgeois, MD, MPH, of Boston Children's Hospital, told us at the time that the researchers found more than 69,000 children were involved in studies that were completed, but that were never published in scientific literature. “As a result, these trials fail to contribute to our scientific knowledge and to inform the clinical care we can provide to children,” he added.
Ultimately, while legislation and increased resources have helped address many barriers to initiating and conducting clinical trials in children, researchers still face several unique challenges.