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Pediatric Oncology Trials: Changes on the Horizon

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December 13, 2016

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Developers of oncology therapeutics will want to closely follow the Research to Accelerate Cures and Equity for Children Act, aka the RACE for Children Act, introduced in both the U.S. House and Senate in July.  This bill has the potential to dramatically alter the pediatric oncology landscape by expanding Pediatric Research Equity Act (PREA) requirements for oncology therapeutics.  The obligation to conduct pediatric trials would no longer be predicated on the adult oncologic indication being relevant for children, but would instead be triggered if the drug or biologic is directed at a molecular target that is relevant to a pediatric cancer.  Also, orphan designation would no longer exempt such products from PREA requirements.