Alzheimer's Disease (AD) and AD-Related Dementias (ADRD) Real-World Data Platform (U54 Clinical Trial Optional) | RFA AG 24 009

Opportunity Information: Apply for RFA AG 24 009

The National Institutes of Health (NIH) is soliciting applications under Funding Opportunity Number RFA-AG-24-009 for a cooperative agreement to build and operate an Alzheimer’s Disease (AD) and Alzheimer’s Disease-Related Dementias (ADRD) Real-World Data (RWD) Platform. The mechanism is a U54 (clinical trial optional), which typically supports large, multi-component centers or platforms and is structured as a cooperative agreement, meaning NIH program staff will have substantial involvement in steering, oversight, and coordination as the project develops. The overall intent is to create a central, shared hub that researchers can use to access and work with real-world datasets relevant to AD/ADRD, rather than relying only on traditional, stand-alone studies or randomized clinical trials.

The platform’s goals are framed around four practical research needs. First, it aims to improve the applicability and generalizability of AD/ADRD findings by enabling analyses on much larger datasets that include more diverse populations than are often represented in conventional research cohorts. This emphasis on diversity reflects a longstanding challenge in dementia research, where study populations may not match the demographics of the communities most affected, limiting the usefulness of results in real clinical and community settings. Second, the platform is intended to make information more complete by linking different kinds of data sources. In real-world research, important signals about diagnosis, treatment, outcomes, and social or environmental context are often fragmented across health systems, claims files, registries, imaging or laboratory repositories, and other sources. A linked approach can provide a more holistic picture of disease progression, care pathways, and outcomes than any single dataset alone.

Third, the initiative is designed to increase the speed at which scientific questions can be answered. When data are difficult to find, hard to access, or incompatible across sites, it can take years just to assemble an analytic dataset. A centralized platform can reduce that friction by standardizing access processes, harmonizing data elements where possible, and supporting repeatable workflows that let investigators move faster from question to analysis. Fourth, the platform is explicitly aimed at strengthening researchers’ ability to answer questions that are not feasible or readily answered through clinical trials. Many policy, health services, long-term outcome, safety, comparative effectiveness, and equity questions are impractical to test in randomized trials due to cost, time, ethical constraints, or the complexity of real-world care. A robust RWD platform can support those lines of inquiry while complementing, not replacing, clinical trial research.

Eligibility for this opportunity is broad and includes many types of domestic organizations and governmental entities. Eligible applicants listed include state, county, and city or township 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 Native American tribal organizations that are not federally recognized tribal governments. The FOA also allows public housing authorities/Indian housing authorities, small businesses, for-profit organizations other than small businesses, and nonprofit organizations both with and without 501(c)(3) IRS status (excluding institutions of higher education in those nonprofit categories). The announcement also highlights additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations and certain eligible federal agencies. U.S. territories or possessions and regional organizations are also included among the eligible applicant types.

Foreign eligibility is more limited and is spelled out directly. Non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply as the applicant organization. However, non-domestic components of U.S. organizations are eligible to apply as part of a U.S.-based applicant, and foreign components (as defined by the NIH Grants Policy Statement) are allowed. In practice, that means the lead applicant must be a domestic eligible entity, but the project can include some work performed internationally if it meets NIH’s definition and approval requirements for foreign components.

The opportunity is categorized as discretionary funding in the health area and is associated with CFDA numbers 93.853 and 93.866. The posted award ceiling is $52,000,000, signaling NIH’s interest in supporting a large-scale, high-impact infrastructure effort rather than a small, single-lab research project. The listing shows an original closing date of 2023-07-31 and a creation date of 2023-03-13, which are useful for situating the timeline of the solicitation. Overall, the FOA is centered on building shared infrastructure that expands access to linked, diverse real-world AD/ADRD data and makes it easier and faster for the research community to generate evidence that better reflects how dementia is experienced, diagnosed, and treated in everyday settings.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Alzheimer's Disease (AD) and AD-Related Dementias (ADRD) Real-World Data Platform (U54 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853, 93.866.
• This funding opportunity was created on 2023-03-13.
• Applicants must submit their applications by 2023-07-31. (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 $52,000,000.00 in funding.
• 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.

Apply for RFA AG 24 009

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