How RACE legislation is changing the face of pediatric oncology in the US
On August 12 of this year the US senate unanimously passed the Race to Accelerate Cures and Equity for Children Act (RACE) expanding on the already enacted Pediatric Research Equity Act (PREA).
This legislation was passed as within the US, cancer remains the top cause of disease-related-deaths in children, and it is designed to drive the industry towards providing a greater range of treatments for what is a relatively small patient population.
So, what does this mean? The legislation applies to new drug and biologic applications made 18 months following its introduction into US law. Previously under the PREA for an indication which affects children, pediatric trials were required for new active ingredients, indications, dosage forms, dosing regimens and routes of administration. Within oncology this new legislation ups the ante – requiring specific pediatric trials if the drug or biologic is aimed at a cancer which is present within the pediatric population. Additionally, the previous laws exempted therapies with orphan designation, which is no longer the case under RACE.
These changes have the potential to change the pediatric oncology landscape dramatically. This is a major improvement from the patient perspective, but has now become an area which requires consideration and careful navigation from industry to ensure the complexities are dealt with.
Earlier this year IQVIA published a paper outlining the impact of the new bill and considering the specific consideration with regards to planning and executing pediatric trials accordingly.
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