The Bolstering Research And Innovation Now (BRAIN) Act seeks to strengthen research and treatment development for brain tumors, while also improving awareness, adequacy, and access to specialized care. It addresses the critical need for advancements, given that brain tumors affect over a million Americans and have stagnant survival rates, particularly for aggressive forms like glioblastoma. The bill recognizes the lack of early detection or prevention and the limited FDA-approved treatments, aiming to rectify these challenges.

To foster research, the Act mandates the establishment of a searchable website for brain tumor biospecimen collections funded by the National Institutes of Health, requiring reporting from entities maintaining these collections. It also establishes the Glioblastoma Therapeutics Network to evaluate therapeutic agents from pre-clinical to early-phase clinical trials, authorizing $50 million annually for fiscal years 2026-2030. Additionally, it supports the development of brain tumor related cellular immunotherapy, including CAR-T treatments, through multi-institutional team science approaches, with $10 million authorized annually for the same period.

The bill directs the Secretary to carry out a national public awareness campaign to increase knowledge among healthcare providers and individuals about cancer clinical trials and biomarker testing. This campaign will include written materials, public service announcements, and targeted communications for specific populations and rural communities. Furthermore, it establishes demonstration projects to evaluate evidence-based outreach strategies for increasing awareness of clinical trials and biomarker testing among patients, families, and healthcare professionals, with a preference for applicants with expertise in brain tumors and reaching underserved areas.

To enhance patient support, the Act authorizes pilot programs to develop, study, or evaluate approaches for monitoring and caring for adult and pediatric brain tumor survivors throughout their lifespan. These programs can explore models for multidisciplinary care, psychosocial support, and the secure electronic transfer of treatment information, with $5 million authorized annually for fiscal years 2026-2030. Finally, it requires the FDA to issue guidance within one year to minimize the exclusion of brain tumor patients and those with rare cancers from clinical trials for other indications.