On July 13, the Association for Clinical Oncology (ASCO) provided comments on a recently released 21st Century Cures 2.0 Act discussion draft and accompanying Advanced Research Projects Agency Health (ARPA-H) request for information (RFI).
In its comment letter to Representatives Diana DeGette (D-CO) and Fred Upton (R-MI), who are spearheading this legislation, ASCO applauded the inclusion of provisions to improve diversity in clinical trial participation in the discussion draft. Specifically, the draft would require private payers to cover routine care costs associated with participation in Patient-Centered Outcomes Research Institute (PCORI) clinical trials. The draft also includes a provision to provide grants to explore innovative clinical trial design.
ASCO also thanked the Members of Congress for including two of ASCO’s legislative priorities in the discussion draft:
- The Telehealth Modernization Act would make permanent telehealth flexibilities that were established during the COVID-19 public health emergency to allow more patients and providers to continue to benefit from the use of telehealth.
- The Research Investment to Spark the Economy Act (RISE) would provide $25 billion in emergency supplemental funding for several agencies focused on research, including the National Institutes of Health (NIH), to help mitigate pandemic-related research disruptions.
Advanced Research Projects Agency Health (ARPA-H)
The Cures 2.0 discussion draft also includes a section on the establishment of ARPA-H, the Biden Administration’s proposed new biomedical research agency focused on high-risk, bold, translational research projects. Representatives DeGette and Upton posed several questions to stakeholders on how ARPA-H should be organized, where it should be located, what types of projects it should focus on, how it should engage with different stakeholders, and how it could be appropriately funded.
ASCO’s response included:
- Funding for ARPA-H should not jeopardize funding for existing federal research. Congress must continue to make meaningful, reliable annual funding increases for the NIH and National Cancer Institute (NCI) baseline budgets.
- ARPA-H should focus on high-risk, high-reward research that would fill a gap in the current biomedical research enterprise. The proposed agency should not duplicate research currently funded by NIH, NCI, or underway in the commercial sector, and should maintain an environment of two-way collaboration, rather than competition.
- Equity considerations (including race, ethnicity, gender/gender identity, sexual orientation, disability, and income level) must be woven throughout the projects ARPA-H funds, and ARPA-H should implement strategies to encourage broad inclusion criteria, decentralization of clinical trials, eliminating inequities in research, and advancing the research on disparities.
- Any new therapeutics and treatments coming from ARPA-H funded research should be affordable and accessible to all patients.
- ARPA-H should have flexibility to recruit and hire from outside the traditional civil service hiring process and provide competitive salaries. Project managers must have authority for projects to “fail” without fear of the agency losing annual appropriations.
- ARPA-H should directly and routinely engage patients, clinicians, and researchers to inform the organization and function of the new agency, and should regularly consult specialty organizations, like ASCO, for their knowledge and expertise during the creation and implementation of ARPA-H and for special projects.
ASCO will continue to provide feedback on Cures 2.0 and ARPA-H over the coming months.
Read ASCO’s comment letter.
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