KUALA LUMPUR, June 19 — Seventy-eight novel adult cancer agents were approved by the United States Food and Drug Administration between 2007-2017, but none of those drugs were researched to determine effectiveness for pediatric cancers.
That is about to change on Aug 18 when The Research to Accelerate Cures and Equity for Children Act (RACE Act) goes into effect. Passed in 2017, the RACE Act amends the existing Pediatric Research Equity Act (PREA) and eliminates the exemption from PREA requirements for cancer drugs that have orphan status.
According to a statement, the new law requires pediatric evaluation of new drugs and biologics intended for the treatment of adult cancers and directed at a molecular target substantially relevant to the growth or progression of pediatric cancer.
Clinical research companies and their pediatric research specialists, including PRA Health Sciences, will be called on to support pharmaceutical and biotech companies as they sponsor the required research for pediatric oncology indications.
“We are now 60 days away from the RACE Act going into effect, which has created a scramble to develop pediatric study plans for oncology studies,” said Vice-President for The Center for Pediatric Clinical Development at PRA Health Sciences, Dr Mark Sorrentino.
Together, with the addition of dozens of other PRA researchers and pediatric specialists, the team is ready to utilise their collective experience in pediatric clinical development to support RACE Act-focused initiatives.
PRA Health Sciences is one of the world’s leading global contract research organisations by revenue, providing outsourced clinical development and data solution services to the biotechnology and pharmaceutical industries.
— BERNAMA
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