BRAIN Act

Fostering Reporting of Brain Tumor Biospecimen Collections to Help Start Brain Tumor Research 

Creates a new policy that requires researchers who’ve received funding from the National Cancer Institute (NCI) to submit information on their laboratory’s inventory of research samples and materials (tissue specimens and lab models) to a publically available database. This new information sharing policy would help foster greater collaboration in the cancer research field.

• In cancer research, the ability to access biospecimens (blood, tissue, cerebral spinal fluid, etc.) is important to understanding cancers and for evaluating potential treatments and diagnostics, but the current process can be very difficult. Establishing a reliable way of knowing which researchers, hospitals, and labs have biospecimen collections can make it easier to figure out who to contact about possible sharing of biospecimens.
  
• NIH’s data sharing policy is largely voluntary and currently does not require researchers to “raise their hand” and report the existence of biospecimen collections (even though they were supported with public dollars). 
  
• NCI already has a specimen resource locator website that could be used. Currently, participation is voluntary and thus, not used very much. 
  
• This policy change increases transparency of publicly-funded research resources. 
  
• Exceptions to reporting requirements may be made to maintain legally required confidentiality. 
  
• This provision does not require sharing of the actual biospecimens, only reporting of collections.
  

Providing the NCI’s Glioblastoma Therapeutics Network (GTN) Necessary Funding to Innovate Glioblastoma Research and Give Patients a Greater Chance at Survival 

Increases the National Cancer Institute’s Glioblastoma Therapeutics Network’s annual budget to at least $50 million annually for fiscal years 2025 through 2029. 

• This section calls for making whole and scaling up the GTN to take on glioblastoma, which the National Cancer Institute has called “a disease that is one of the hardest to treat in all of oncology” and more than 13,000 Americans are diagnosed with each year.
  
• GTN is a network of world-class medical academic centers funded together as a collaborative under an NIH U19 grant to evaluate, in labs and then in human clinical trials, promising treatments for patients with glioblastoma.
  
• Current institutions include UCSF, Brigham & Women’s Hospital, Yale, Mayo Clinic, City of Hope, Northwestern, and Duke.
  
• The network was developed from the consensus of the National Cancer Institute’s Glioblastoma Working Group in 2019.
  
• The network is charged with taking on the most aggressive, treatment-resistant cancer, but its funding levels are insufficient to both conduct laboratory studies and also to operate early phase clinical trials as intended. Additionally, the National Cancer Institute cut the awardees’ funding by 20 percent in the first year after originally promising $6M per year for 5 years. 

Fostering Team Science in an Emerging Area of Brain Cancer Research: CAR-T 

Directs the National Cancer Institute to establish a new collaborative U-type funding award of $10M for each fiscal year 2025 through 2033 to advance promising chimeric antigen receptor (CAR-T) immunotherapy research. 

• Glioblastomas are immunologically “cold” tumors making it thus far difficult to use immunotherapies that work for other cancers to treat patients with glioblastoma (GBM).
  
• There is growing scientific evidence and hope behind chimeric antigen receptor T-cell therapy (CAR-T), a form of immunotherapy expected to have potential therapeutic benefits for patients with glioblastoma. Now is the time for team science investment to determine if this form of immunotherapy research can advance into effective treatments for adults and children with the most deadly brain tumors. 
  
• This provision would establish new funding within the National Cancer Institute for a five-year grant mechanism using an NIH “U-type” cooperative agreement for CAR-T in brain tumors and in doing so would help bring leading cancer centers together, further leveraging their resources.
  

Driving Awareness to Improve Care

Directs the Secretary of Health and Human Services (HHS) through the Centers for Disease Control (CDC) to conduct a public education campaign to increase the awareness and knowledge of health care providers and individuals concerning the importance of clinical trials and biomarker testing in cancer treatment. 

• This section aims for the Centers for Disease Control, which runs the Comprehensive Cancer program, to add clinical trials and biomarker testing as a priority area and to include clinical trials and biomarker testing awareness among the public health campaigns that it funds and promotes.
  
• It also calls for demonstration projects that pilot efforts to intensify access to and delivery of comprehensive biomarker testing for patients where evidence shows that there is a lack of testing sufficiency. 
  
• Biomarker testing is a way to look for genes, proteins, and other substances (called biomarkers) that can provide cancer information. Each person’s cancer has a unique pattern of biomarkers. Some biomarkers affect how certain cancer treatments work.
  
• Biomarker testing helps patients and their medical providers diagnose cancer and determine appropriate courses of treatment including eligibility for clinical trials.
  
• The current National Comprehensive Cancer Network’s guidelines call for cancer clinical trials to be considered in many cases including in brain tumors.
  
• If clinical trial awareness and biomarker testing were part of mass education efforts across states, it could lead to benefits such as: 
  
  • Improved diversity in cancer clinical trials 
  • Improved accrual 
  • Improved patient knowledge of their cancer, leading to more informed decisions
  • Better matching of patients to treatments based on their biomarkers
    

Innovating Health Care Delivery & Enhancing Brain Tumor Survivorship

Provides funding and allows the Secretary of HHS – through the National Institutes of Health (NIH), including the National Cancer Institute’s Office of Cancer Survivorship –  to make awards to eligible entities to establish programs to develop, study, or evaluate model systems for monitoring and caring for adult, adolescent, and pediatric brain tumor survivors throughout their lifespan, including evaluation of current health care models for transition to post-treatment care and care coordination. 

• This provision calls for grants made by the NIH to foster needed innovation in health care delivery. 
  
• Quality of life for patients living with brain tumors ranges significantly with many different health outcomes. With so many adult and pediatric survivors of different types of brain tumors, it is important to develop appropriate innovative care systems for patients and their families including in palliative care and various settings including educational, social, community, and family.
  

Making Clinical Trials More Accessible to a Greater Number of Patients

Requires the FDA to develop new guidance to industry to help identify ways to reduce exclusion of brain tumor patients and other patients with rare and recalcitrant cancers from clinical trials evaluating treatments for other indications.

• This section calls for the FDA to develop guidance to help sponsors reduce this problem in ways that maintain the validity of clinical trials.
  
• Currently there is no FDA guidance document that specifically covers issues related to how to reduce exclusion in therapeutic (cancer and non-cancer) clinical trials based upon chronic condition/disease.
  
• Cancer patients may be excluded from clinical trials evaluating treatments for other diseases and conditions just because they have cancer.