Applied Regulatory Science Research to Understand Factors that Affect the Safety and Efficacy of Underrepresented Populations in Oncology Therapeutic Development (U01) Clinical Trial Optional | RFA FD 23 006

Opportunity Information: Apply for RFA FD 23 006

The grant opportunity titled "Applied Regulatory Science Research to Understand Factors that Affect the Safety and Efficacy of Underrepresented Populations in Oncology Therapeutic Development (U01) Clinical Trial Optional" (Funding Opportunity Number RFA-FD-23-006) is a cooperative agreement funded by the U.S. Department of Health and Human Services through the Food and Drug Administration (FDA). It sits in the applied regulatory science space, meaning the projects it supports are expected to generate practical, decision-relevant evidence that can inform how oncology drugs are developed, evaluated, and ultimately regulated, especially when it comes to groups that have not historically been well represented in cancer clinical trials. The FOA is explicitly focused on improving understanding of factors that influence both safety and efficacy outcomes of oncology therapeutics for underrepresented populations, with particular emphasis on racial and ethnic minorities, sex and gender minorities, and older adults.

At its core, this opportunity is about closing evidence gaps that can arise when trial populations do not reflect the diversity of patients who will use these therapies in the real world. In oncology, differences in biology, comorbidities, concomitant medications, organ function, social determinants of health, access to care, and patterns of treatment can all affect how safe or effective a therapy appears once it leaves the controlled environment of a traditional trial. By supporting applied research that clarifies these influences, the FDA is aiming to strengthen the scientific foundation used to interpret clinical data, assess benefit-risk profiles, and design future studies in ways that better capture clinically meaningful variation across populations.

The funding mechanism is a U01 cooperative agreement, which generally indicates substantial federal scientific and programmatic involvement during the project period compared with a standard grant. In practice, that typically means awardees should expect active collaboration with FDA staff around study design considerations, regulatory relevance, data standards or endpoints, and the kinds of outputs that are most useful for regulatory science. The "Clinical Trial Optional" designation signals that applicants may propose research that includes a clinical trial, but it is not required; projects could also be based on observational approaches, secondary analyses of existing datasets, real-world data and evidence strategies, methodological work, or other translational and regulatory-science-oriented research designs, provided the work addresses the FOA purpose.

Eligibility is broad and includes many types of organizations that could credibly execute this kind of work. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations both with and without 501(c)(3) status; for-profit organizations other than small businesses; small businesses; and other entities as allowed under the announcement's additional eligibility language. This wide eligibility pool suggests the FDA is open to academic, health system, community-based, nonprofit, and industry-adjacent teams, as long as the proposed research is rigorous and clearly tied to regulatory science questions about underrepresented groups in oncology therapeutics.

From a funding and scale standpoint, the FOA lists an award ceiling of $2,500,000 and anticipates making 2 awards. That combination implies a competitive program likely designed to fund a small number of relatively substantial, well-scoped projects capable of producing actionable insights. The opportunity was created on December 15, 2022, with an original closing date of February 22, 2023, which places it in a specific historical application window; anyone planning a similar submission today would generally use this as a reference point for the FDA's priorities and may need to look for reissued or related FDA funding announcements addressing similar themes.

Overall, the announcement is best understood as an FDA effort to support evidence generation that improves how oncology therapies are assessed for people who have too often been left out of the datasets that drive drug development decisions. The intended outcome is not just descriptive knowledge about disparities, but practical findings that can shape better trial design, better analysis strategies, and more reliable conclusions about safety and efficacy across real patient populations, particularly those defined by race/ethnicity, sex and gender identity, and age.

• The Department of Health and Human Services, Food and Drug Administration in the consumer protection, science and technology and other research and development sector is offering a public funding opportunity titled "Applied Regulatory Science Research to Understand Factors that Affect the Safety and Efficacy of Underrepresented Populations in Oncology Therapeutic Development (U01) Clinical Trial Optional" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
• This funding opportunity was created on Dec 15, 2022.
• Applicants must submit their applications by Feb 22, 2023. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $2,500,000.00 in funding.
• The number of recipients for this funding is limited to 2 candidate(s).
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).

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