PRA looks to bring child-friendly solutions to pediatric clinical trials
“We launched the center to act as a central repository of all pediatric knowledge for both internal and external stakeholders,” Mark Sorrentino, MD, MS, VP at The Center for Pediatric Clinical Development.
“Given the current regulatory environment requiring studies earlier in the clinical development process, we feel our clients are looking for innovation in this space,” he said.
In addition, Sorrentino explained about 70% of all medicines used for children are used off label and haven’t been through a randomized trial. “We hope that our ability to bring innovative solutions to these trials will help bring properly studied medicines to this vulnerable population,” he added.
The center enables the Raleigh, North Carolina-based contract research organization (CRO) to organize its pediatric expertise across functional areas into a “single global resource,” added Sorrentino.
“Our pediatric collaboration team will be able to review protocols and provide feedback and ideas to teams from proposal phase to end-of-trial activities,” he explained.
Next steps include forming a global pediatric site network.
“In addition, we are partnering with external companies who innovate using technology platforms and other child friendly concepts to make participation in a clinical trial a more educated and pleasant experience,” said Sorrentino.