U.S. law requiring clinical research for pediatric oncology treatments goes into effect mid-August 2020
RALEIGH, N.C., June 18, 2020 (GLOBE NEWSWIRE) — Between 2007-2017, 78 novel adult cancer agents were approved by the U.S. Food and Drug Administration,1 but none of those drugs were researched to determine effectiveness for pediatric cancers.
That is about to change on August 18 when the RACE Act – The Research to Accelerate Cures and Equity for Children Act – goes into effect. Passed in 2017, the RACE Act amends the existing PREA – Pediatric Research Equity Act – and eliminates the exemption from PREA requirements for cancer drugs that have orphan status. 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 Dr. Mark Sorrentino, VP, The Center for Pediatric Clinical Development at PRA Health Sciences. “Here at PRA,
we have been preparing for the RACE Act since it was passed in 2017, so we are able to quickly and effectively support our clients and sponsors looking to conduct this research. We have brought together a highly credentialed team internally to serve as hands-on consultants in the development and execution of pediatric research plans.”
PRA’s Center for Pediatric Clinical Development and the team working on the RACE Act implementation include Dr. Sorrentino as well as Dr. Martine Dehlinger-Kremer, VP, Scientific Affairs, Pediatric Subject Matter Expert; Dr. Jacqui Whiteway, Senior Pediatric Strategy Liaison; Jo Dewhurst, LLB Dip; and Missy Hansen, MSN, APRN, CNP-Pediatrics, Pediatric Strategy Liaison. Together, with the addition of dozens of other PRA researchers and pediatric specialists, this designated team of experts is ready to utilize their collective experience in pediatric clinical development to support RACE Act-focused initiatives.
“Parents and pediatric oncologists need to have confidence that the therapies and treatments they are giving to their children are safe and effective for fighting cancer in pediatric patients,” Dr. Dehlinger-Kremer said. “The RACE Act is pushing all of us – drug developers, researchers, and medical care teams – to find the best treatments possible for children and their families, and to develop treatments that are specifically tailored to children.”
- White Paper: Parents as Gatekeepers for Children with Cancer
- Insight: The RACE Act is coming this August. Here’s what you need to know.
- Video: Learn more about the RACE Act from PRA’s experts.
With the RACE Act going into effect, the law has caught up with the critical need for drug developers to focus on pediatric oncology.
- Since 1980, only four oncology drugs were first approved for use in children2
- Only 4 percent of funding spent on cancer research is directed toward childhood cancer3
- Cancer drugs approved by the FDA take a median of 6.5 years to go from first clinical trial in adults to the first trial in children4
- While considered a rare condition, 46 children are diagnosed with cancer each day5 and those patients, their families, and their medical teams need more treatments suitable for pediatric indications
“From a research perspective, there is so much more we can do to improve kids’ lives,” Dr. Sorrentino said. “PRA has conducted more than 130 pediatric studies in the last five years, and our promise, to the kids and their families, is to work quickly and safely, specifically with them in mind, to develop treatment options that will be effective for our smallest patients. It’s going to take a collective team effort between drug developers and researchers – we are ready for that challenge.”
For more information on the RACE Act, visit https://prahs.com/centers/the-
About PRA Health Sciences
PRA Health Sciences is one of the world’s leading global contract research organizations by revenue, providing outsourced clinical development and data solution services to the biotechnology and pharmaceutical industries. PRA’s global clinical development platform includes more than 75 offices across North America, Europe, Asia, Latin America, South Africa, Australia and the Middle East and more than 17,500 employees worldwide. Since 2000, PRA has participated in approximately 4,000 clinical trials worldwide. In addition, PRA has participated in the pivotal or supportive trials that led to U.S. Food and Drug Administration or international regulatory approval of more than 95 drugs. To learn more about PRA, please visit www.prahs.com.
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- Hwang T.J., et al. Pediatric trials for cancer therapies with targets potentially relevant to pediatric cancers. Journal National Cancer Institute (2020) 112(3): djz207.
- Coalition Against Childhood Cancer. Childhood Cancer Fact Library (2017). https://cac2.org/childhood-
cancer-fact-library-2017/#:~: text=Since%201980%2C%20only% 20four%20drugs,use%20in% 20high%2Drisk%20neuroblastoma.
- Dylan V. Neel, David S. Shulman, Steven G. DuBois. Timing of first-in-child trials of FDA-approved oncology drugs. European Journal of Cancer, 2019; 112: 49 DOI: 10.1016/j.ejca.2019.02.