INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Clinical Trial Readiness (R21 Clinical Trial Not Allowed) | RFA OD 22 007

Opportunity Information: Apply for RFA OD 22 007

The NIH INCLUDE Project funding opportunity, titled "INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Clinical Trial Readiness (R21 Clinical Trial Not Allowed)," supports short, focused clinical research projects aimed at getting the Down syndrome field better prepared for future clinical trials. The overall purpose is to improve health and quality of life for people with Down syndrome by strengthening the practical building blocks needed to move promising therapeutics and diagnostics toward well-designed, feasible, and informative trials. This is an R21 mechanism, which is typically used for exploratory or early-stage projects that can generate key proof-of-concept data, but it explicitly does not allow clinical trials under this announcement, meaning applicants should focus on trial-enabling work rather than testing an intervention for efficacy in a trial setting.

A central theme of the announcement is "clinical trial readiness." In practice, this means the FOA is looking for projects that solve common bottlenecks that slow or derail trials in Down syndrome or in conditions that commonly co-occur with Down syndrome across the lifespan. The opportunity emphasizes research that makes it easier and more reliable to evaluate candidate treatments or diagnostic tools later on by improving how outcomes are measured, how participants are identified and enrolled, and how the natural history of co-occurring conditions is characterized. The NIH is essentially asking for work that reduces uncertainty before trials begin, so that when a therapeutic or diagnostic is ready, the field has validated tools, clear endpoints, realistic recruitment approaches, and a well-understood clinical course to build a strong protocol.

The types of projects encouraged fall into several major categories. One category is the development and testing of biomarkers, along with clinical outcome assessment measures, that can be used as sensitive, meaningful endpoints in future trials. This includes work to identify markers that track disease risk, onset, progression, or response potential in Down syndrome populations, and to evaluate whether those markers are practical and reliable across different ages and levels of functioning. Another category is the development and testing of novel trial methods and recruitment strategies. This can involve addressing common barriers to enrolling participants with Down syndrome, improving retention, adapting assessment procedures so they are feasible and acceptable, or designing methods that make multisite studies more consistent. A third category focuses on defining the presentation and course of co-occurring conditions in individuals with Down syndrome. By clarifying when conditions typically emerge, how they progress, and what clinical features or subgroups exist, researchers can help future trial designers choose the right target population, timing, endpoints, and follow-up duration.

The opportunity is offered by the National Institutes of Health (NIH) as a discretionary grant program under Funding Opportunity Number RFA-OD-22-007. It is associated with multiple CFDA numbers (93.173, 93.394, 93.395, 93.846, 93.853, 93.865, 93.866, 93.867), reflecting the cross-institute and cross-topic nature of INCLUDE and related NIH activities. The program is structured to support clinical projects that are preparatory in nature, helping the research ecosystem reach the point where later-stage clinical trials can be launched more efficiently and with a higher chance of producing clear, actionable results.

In terms of who can apply, eligibility is broad and includes many kinds of U.S. organizations and some non-U.S. 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; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status (as long as they are not institutions of higher education in those categories); for-profit organizations other than small businesses; and small businesses. The announcement also calls out additional eligible groups such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-domestic (foreign) entities. This wide eligibility reflects the NIH interest in expanding capacity, partnerships, and representation in Down syndrome research, including community-connected organizations and institutions serving historically underrepresented populations.

Key logistics included in the source information are an award ceiling of $275,000 and an original closing date of July 1, 2024, with the opportunity first created on April 5, 2022. While the summary provided does not specify the number of expected awards, the overall intent is clear: fund targeted, clinically relevant studies that can supply the field with validated measures, better recruitment and study procedures, and clearer characterization of co-occurring conditions, so that future Down syndrome trials can be designed with stronger scientific rationale, better endpoints, and more realistic operational plans.

• The National Institutes of Health in the education, health, income security and social services sector is offering a public funding opportunity titled "INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Clinical Trial Readiness (R21 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.173, 93.394, 93.395, 93.846, 93.853, 93.865, 93.866, 93.867.
• This funding opportunity was created on 2022-04-05.
• Applicants must submit their applications by 2024-07-01. (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 $275,000.00 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.

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