The RACE for Children Act Will Change the Landscape for Pediatric Cancer Research: Are you ready for August 2020?
As part of the 2017 FDA Reauthorization Act (FDARA), the RACE for Children Act amended the Pediatric Research Equity Act (PREA) leading to considerable changes in the regulations governing the development of cancer therapies for children. Set to go into effect in August 2020, this law focuses on the requirement for clinically meaningful evaluation of drugs directed at specific molecular targets relevant in pediatric cancer. Shifting the focus from indications to molecular targets, this law eliminates orphan exemptions for pediatric studies for oncology indications. As such, the RACE for Children Act is positioned to considerably change the regulatory landscape of oncology therapy development.
In this webinar, we explore the regulatory implications of the RACE for Children Act and what this law means for your development program, particularly with navigating the change in requirements for pediatric oncology trials. Furthermore, we explore the challenges of executing oncology trials in pediatric populations and offer insight into design and operational aspects to seamlessly execute these studies as part of your clinical development plan. Key topics include:
- Regulatory – requirements of the RACE for Children Act and how this impacts your regulatory strategy and clinical development plans, including study designs
- Pediatric oncology trial management, operational challenges and considerations for efficient and accelerated execution