If passed, the bill would authorize the Secretary of Health and Human Services to develop and maintain a registry to aggregate real-world data that can aid in creating external control groups for pediatric brain tumor clinical trials. This initiative aims to provide crucial insights that could guide treatment methodologies and development, particularly for ultra-rare tumors where traditional clinical trial participation is not feasible. The Secretary will be empowered to collaborate with academic institutions and private entities to implement this program effectively.
Summary
House Bill 6288, known as the 'Data for Pediatric Brain Cancer Act of 2023', seeks to amend the Federal Food, Drug, and Cosmetic Act to establish a Pediatric Brain Tumor Real-World Data Registry Program. The primary goal of the bill is to enhance data collection, sharing, and utilization for children diagnosed with brain tumors, particularly focusing on atypical teratoid rhabdoid tumor (ATRT), a rare and aggressive form of brain cancer. The bill emphasizes the importance of real-world data in clinical research, especially when randomized clinical trials are challenging due to the rarity of these diseases.
Contention
While the bill is largely focused on improving cancer treatment options for children, it may face discussions regarding the allocation of funds and resources needed for the implementation of the registry. The bill authorizes $2 million for the fiscal year 2025, raising questions about the long-term funding and sustainability of such data collection programs. Stakeholders may express concerns about the adequacy of these resources in relation to the rising complexities of pediatric cancer treatment and research needs.
A resolution expressing support for the designation of May 17, 2023, as "DIPG Pediatric Brain Cancer Awareness Day" to raise awareness of, and encourage research on, diffuse intrinsic pontine glioma tumors and pediatric cancers in general.
A resolution expressing support for the designation of May 17, 2024, as "DIPG Pediatric Brain Cancer Awareness Day" to raise awareness of, and encourage research on, diffuse intrinsic pontine glioma tumors and pediatric cancers in general.