Small R01s for Clinical Trials Targeting Diseases within the Mission of NIDDK (R01 Clinical Trial Required) | PAS 20 160

Opportunity Information: Apply for PAS 20 160

The grant opportunity "Small R01s for Clinical Trials Targeting Diseases within the Mission of NIDDK (R01 Clinical Trial Required)" (Funding Opportunity Number PAS 20 160) is an NIH funding announcement designed to support early-stage, real-world clinical trials in humans that can serve as a springboard to larger, more definitive studies. The core purpose is to fund pilot and feasibility clinical trials that focus on the prevention and/or treatment of diseases and conditions that fall under the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) mission area. In practical terms, this means the program is geared toward smaller, shorter-term trials that help researchers determine whether a proposed intervention and trial design are workable and promising enough to justify a future, fully powered, hypothesis-driven clinical trial that could change clinical practice or meaningfully influence public health.

A defining feature of this FOA is its emphasis on generating preliminary human data in two broad categories: early signals about the effects of an intervention and concrete feasibility information about running the trial. On the intervention side, the study is expected to collect initial outcome data that can indicate whether the intervention has the intended direction or magnitude of effect, even if it is not yet definitive. On the feasibility side, the trial should produce practical evidence on whether participants can be recruited efficiently, whether they can be retained and followed over time, and whether the study procedures can be carried out as planned (for example, whether the protocol is acceptable to participants, whether data collection methods work smoothly, and whether adherence and visit completion are realistic). The overall expectation is that the pilot trial will reduce uncertainty and risk before investing in a larger, confirmatory trial.

Applications submitted under this opportunity are expected to present clearly described aims and objectives, with a trial design that is tightly aligned to what the study can realistically accomplish in a small R01. Reviewers are looking for a strong likelihood that the results will directly inform the next step: a more definitive clinical trial that is hypothesis-driven and positioned to improve understanding, diagnosis, prevention, or treatment of the targeted disease or condition. A key point is that preliminary data demonstrating intervention efficacy are not required to apply. This lowers the barrier for investigators who have a compelling rationale and a solid, testable approach, but who still need early human data and feasibility metrics to justify a larger trial.

The program uses the NIH R01 grant mechanism and explicitly requires that the application include a clinical trial, meaning the proposed research must involve prospective assignment of human participants to an intervention to evaluate effects on health-related outcomes. The funding activity category is listed under Food and Nutrition and Health (CFDA 93.847), and the opportunity is categorized as a discretionary grant. The award ceiling shown in the source information is $200,000, reflecting the small, focused nature of the supported trials. The announcement was created on March 31, 2020, and the original closing date provided is May 7, 2023 (applicants should typically confirm current due dates and any reissues or updates on NIH and Grants.gov systems, since FOAs can be updated or replaced over time).

Eligibility is broad and includes a wide range of U.S.-based organizations and government entities. 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; nonprofit organizations (both with and without 501(c)(3) status); public housing authorities and Indian housing authorities; for-profit organizations (other than small businesses); and small businesses. It also includes Native American tribal governments that are federally recognized, as well as tribal organizations that are not federally recognized tribal governments. In addition, the FOA highlights several categories of other 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 agencies of the federal government, Indian/Native American Tribal Governments (other than federally recognized), and U.S. territories or possessions.

Restrictions on foreign involvement are specific. Non-domestic (non-U.S.) entities and non-domestic (non-U.S.) institutions are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components are allowed as defined in the NIH Grants Policy Statement, meaning a U.S. applicant may include certain scientifically justified activities conducted outside the U.S. as part of the project, provided they meet NIH policy requirements and are properly justified and approved.

Overall, this FOA is aimed at investigators who have an intervention and a clinical question ready for testing in humans but who need a smaller, time-limited trial to prove the concept and demonstrate that a larger trial is feasible. The strongest proposed projects are those that treat the pilot trial as a deliberate stepping-stone: they specify what preliminary outcome signals will be measured, what feasibility benchmarks will be tracked (recruitment rate, retention, adherence, data completeness, site performance), and how the findings will directly shape a subsequent, larger clinical trial intended to produce definitive evidence in an NIDDK-relevant disease area.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Small R01s for Clinical Trials Targeting Diseases within the Mission of NIDDK (R01 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 2020-03-31.
• Applicants must submit their applications by 2023-05-07. (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.

Apply for PAS 20 160

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