Exploratory Clinical Trial Grants in Arthritis and Musculoskeletal and Skin Diseases (R21 Clinical Trial Required) | PAR 18 595

Opportunity Information: Apply for PAR 18 595

The Exploratory Clinical Trial Grants in Arthritis and Musculoskeletal and Skin Diseases (R21 Clinical Trial Required) opportunity, listed as PAR-18-595, is a National Institutes of Health (NIH) funding announcement designed to support early-stage, exploratory clinical trials that can realistically be finished within a short period of time and with a relatively modest budget. It sits under NIH health research funding (CFDA 93.846) and is aligned with the mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The core idea is to give researchers a way to test promising interventions in humans through smaller, focused clinical trials that generate the kind of preliminary evidence needed to justify larger, more definitive studies later on.

This FOA is explicitly for clinical trials, meaning applicants are expected to propose a study that prospectively assigns human participants to an intervention and evaluates outcomes. NIAMS is open to a broad range of exploratory trial designs and research questions, as long as they clearly fit NIAMS priorities in arthritis, musculoskeletal conditions, and skin diseases. The interventions can include drugs and biologics, but the scope is not limited to pharmaceuticals. The announcement also allows studies evaluating devices, surgical approaches, dietary interventions, behavioral therapies, and rehabilitation strategies. In practice, this gives applicants flexibility to propose trials that reflect real-world treatment options across these disease areas, including non-drug approaches that still require rigorous clinical testing.

The funding mechanism is an R21, which is commonly used by NIH for exploratory and developmental research. Consistent with that purpose, the budget and timeframe are intended to be limited compared with larger clinical trial awards. The source data lists an award ceiling of $400,000, signaling that proposed projects should be scoped appropriately for that cap and for the smaller-scale nature of an R21 clinical trial. While the listing does not specify the number of expected awards, the overall design of the FOA emphasizes feasibility, efficiency, and producing informative signals (for example, early efficacy signals, safety/tolerability information, feasibility metrics, or other outcomes that justify a next-step trial).

Eligibility is broad and includes many common domestic applicant types: state, county, and city/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; public housing authorities/Indian housing authorities; Native American tribal organizations that are not federally recognized governments; nonprofits with and without 501(c)(3) status (excluding higher education institutions in those nonprofit categories); for-profit organizations other than small businesses; and small businesses. The FOA also highlights additional eligible applicants 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, regional organizations, eligible federal agencies, and applicants based in U.S. territories or possessions. This emphasis signals NIAMS interest in encouraging a wide variety of institutions and community-linked organizations to participate in clinical research, including those serving populations that may be underrepresented in biomedical studies.

At the same time, there are clear limits on foreign involvement. Non-domestic (non-U.S.) entities and foreign institutions are stated as not eligible to apply, and non-domestic components of U.S. organizations are also not eligible to apply. However, the FOA allows foreign components as defined under the NIH Grants Policy Statement, which generally means a U.S. applicant may include certain justified international elements in a project when they are necessary for the science and meet NIH policy requirements, even though the primary applicant organization must be domestic and the project cannot be built around an ineligible foreign applicant or a non-domestic organizational component.

Administratively, this is a discretionary grant opportunity from NIH. The listing shows an original closing date of 2020-11-03 and a creation date of 2018-01-26, which is useful context for understanding the lifecycle of the announcement in the federal funding system. Overall, the opportunity is aimed at teams that have a well-defined clinical question in NIAMS-relevant diseases and a trial concept that is tight in scope, can be executed quickly, and fits within the exploratory R21 framework while still meeting NIH expectations for rigor, participant protection, and meaningful clinical outcomes.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Exploratory Clinical Trial Grants in Arthritis and Musculoskeletal and Skin Diseases (R21 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.846.
• This funding opportunity was created on 2018-01-26.
• Applicants must submit their applications by 2020-11-03. (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 $400,000.00 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 PAR 18 595

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