戻る Agenda
On Demand 1 Track 2: The RACE Act: Implications for Pediatric Clinical Development
Session Chair(s)
Sudipta Chakraborty, PhD
Plain Language Summaries / Clinical Trial Transparency Manager
PRA Health Sciences, United States
The Research to Accelerate Cures and Equity (RACE) for Children Act mandates that all sponsors developing targeted cancer treatments in adults must also do so for children with cancer. This act updates the already existing Pediatric Research Equity Act (PREA) by requiring pediatric evaluations when the molecular targets of investigational products are relevant to childhood cancers. The RACE for Children Act also removes the Orphan Designation exemption of pediatric trials. While the RACE for Children Act was enacted in August 2017, it recently went into effect in August 2020. In this on-demand session, the audience will learn more about the implications of the RACE for Children Act on the current landscape of pediatric clinical development. This session will include insights from both a CRO and from the patient advocacy perspective, as collaboration between industry and public partners will be essential to accommodate the shift in oncology drug development due to the RACE Act.
Learning Objective : At the conclusion of this session, participants should be able to:
- Identify the impact of the RACE Act on oncology clinical development
- Discuss ways that the RACE Act affects medical writing and regulatory affairs
- Recognize the importance of patient advocacy groups and public partners in facilitating the shift in pediatric clinical development due to the RACE Act
Speaker(s)
Speaker
Jacqui Whiteway, PhD
ICON, Canada
Senior Director, Centre for Paediatric Clinical Development