Pilot and Feasibility Therapeutic Clinical Trials in Diabetes, and Endocrine and Metabolic Diseases (R21- Clinical Trial Required) | PA 18 405

Opportunity Information: Apply for PA 18 405

The grant opportunity titled "Pilot and Feasibility Therapeutic Clinical Trials in Diabetes, and Endocrine and Metabolic Diseases (R21 - Clinical Trial Required)" (Funding Opportunity Number: PA-18-405) is a discretionary NIH grant program led by the National Institutes of Health, aligned with the mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). It is designed specifically to fund early-stage, short-term therapeutic clinical trials in humans that can generate the kind of practical evidence needed to justify and properly design larger, definitive clinical trials focused on preventing and/or treating diabetes and certain endocrine or genetic metabolic diseases.

At its core, the program is meant to help researchers take a promising treatment idea and test whether it is realistic, safe enough, and effective enough (in a preliminary sense) to warrant a major clinical trial later. These studies are framed as "pilot and feasibility" trials, meaning the goal is not to deliver final, practice-changing proof on day one, but to collect high-value preliminary clinical data. That can include estimates of treatment effects, recruitment and retention performance, adherence and acceptability, outcome measurement performance, and information needed to refine statistical assumptions and power calculations for a subsequent full-scale trial. The expectation is that a successful R21 project under this announcement would directly support planning for a larger and more definitive study that could ultimately impact clinical care or measurable health outcomes.

A key boundary in this announcement is that it is for therapeutic clinical trials rather than mechanistic clinical trials. In other words, the emphasis is on testing an intervention intended to prevent or treat disease in people, with outcomes that support future clinical decision-making, not primarily on exploring biological mechanisms or pathways as the main purpose. Applicants considering a mechanistic trial would generally be steered toward other funding mechanisms that better match that objective, because NIDDK is signaling that this particular FOA is structured around translational, intervention-focused groundwork for later, larger trials.

The funding instrument is an NIH R21 grant, and the opportunity lists an award ceiling of $200,000. While the source text does not spell out every budgeting detail, the ceiling indicates the maximum amount expected under this announcement for a single award based on the provided summary data. The activity area is categorized under Food and Nutrition, Health, and it is associated with CFDA number 93.847. The original closing date shown in the record is 2020-09-07, and the record creation date is 2017-11-21, which is useful context for understanding the timeframe of the posted opportunity.

Eligibility is broad and includes a wide range of organizational types. Eligible applicants 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; Native American tribal governments (federally recognized) as well as tribal organizations that are not federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding higher education institutions in that category); for-profit organizations (other than small businesses); small businesses; and other applicants as allowed under NIH rules. The announcement also explicitly calls out additional eligible applicant categories, emphasizing inclusion of 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 even non-domestic (non-U.S.) entities (foreign organizations). That breadth signals an intent to encourage diverse institutions and community-linked organizations to participate in early clinical testing that could later scale into larger trials.

In practical terms, the best fit projects for this FOA are those that are ready to move into a small, carefully designed therapeutic clinical study in humans, where the main deliverable is credible preliminary evidence and trial-design intelligence. If the study can demonstrate feasibility and generate data that strengthen the rationale and design for a larger confirmatory trial in diabetes, endocrine disease, or genetic metabolic disorders within NIDDKs scope, it aligns well with the purpose of the program.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Pilot and Feasibility Therapeutic Clinical Trials in Diabetes, and Endocrine and Metabolic 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): 93.847.
• This funding opportunity was created on 2017-11-21.
• Applicants must submit their applications by 2020-09-07. (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 $200,000.00 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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