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

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Description

This opportunity supports small, pilot, and feasibility clinical trials in humans that address diseases and conditions within the mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The goal is to generate preliminary data on intervention effects and feasibility (e.g., recruitment, retention, study conduct) to inform the design of larger, definitive, hypothesis-driven clinical trials. These studies are intended to accelerate the development of impactful clinical research by lowering the barrier to entry for innovative ideas that lack extensive preliminary data.

Key features:

• Supports proof-of-concept, short-term clinical trials (not intervention development or observational studies).
• Focuses on prevention and/or treatment of diabetes, other endocrine/metabolic diseases, digestive diseases, nutritional disorders, obesity, kidney, urologic, and hematologic diseases.
• Emphasizes feasibility and operational data as well as preliminary signals of intervention effect.
• Applications must have clearly described aims and a strong rationale for the proposed trial.
• Only clinical trials are eligible; observational studies, animal/in vitro studies, and multi-center trials (three or more distinct clinical centers) are not allowed.

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Due Dates

• June 5, 2025: New applications
• July 5, 2025: Renewal, resubmission, or revision applications (as allowed)
• September 7, 2025: AIDS-related new/renewal/resubmission/revision applications
• October 5, 2025: New applications
• November 5, 2025: Renewal, resubmission, or revision applications
• January 7, 2026: AIDS-related new/renewal/resubmission/revision applications
• February 5, 2026: New applications
• March 5, 2026: Renewal, resubmission, or revision applications
• May 7, 2026: AIDS-related new/renewal/resubmission/revision applications

All applications are due by 5:00 PM local time of the applicant organization. See the NIH standard due dates for more details.

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Funding Amount

• Direct costs: Up to $200,000 per year
• Project period: Maximum of 3 years
• Total program intent: NIDDK intends to commit $1 million in FY2025 to fund up to 3 awards beyond its normal R01 funding policies.
• No cost sharing required.

Budget should reflect the actual needs of the proposed research. See NIH Grants Policy Statement for details.

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Eligibility

Eligible applicants include:

• Public and private institutions of higher education
• Nonprofits (with or without 501(c)(3) status)
• For-profit organizations (including small businesses)
• State, county, city, township, and special district governments
• Independent school districts
• Native American tribal governments and organizations
• Public housing authorities/Indian housing authorities
• Faith-based and community-based organizations
• Regional organizations
• U.S. territories and possessions

Not eligible: Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations. However, foreign components (as defined by NIH) may participate by providing scientific input (e.g., data analysis, laboratory assays).

Note: Only clinical trials are eligible. Observational studies, animal/in vitro studies, and trials with three or more distinct clinical centers are not eligible.

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Application Process

• Submission: Applications must be submitted electronically via Grants.gov or NIH ASSIST.
• Required registrations: Applicant organizations must have active registrations in SAM, eRA Commons, and Grants.gov.
• Application format: Use the SF424 (R&R) forms, Forms-H version.
• Instructions: Follow the NIH How to Apply - Application Guide and the specific instructions in the funding announcement.
• Key attachments:
  • Specific Aims (note the application is in response to PAS-25-102 and does not require preliminary data)
  • Research Strategy (clearly articulate significance, rationale, and how pilot data will inform a future trial)
  • Data Management and Sharing Plan
  • Milestone Plan (for clinical trial progress)
• Review criteria: Scientific merit, innovation, feasibility, investigator expertise, and potential for future impact.

Important: Contact NIDDK program staff early to confirm that your proposed trial fits the institute’s mission and this funding opportunity.

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Additional Information

• Preliminary efficacy data are not required. However, a strong scientific premise and operational feasibility must be justified.
• Only single- or two-center trials are allowed. Multi-center trials (three or more distinct clinical centers) are not eligible.
• No animal or in vitro studies.
• No recruitment of participants from foreign sites. Foreign components may only provide scientific input.
• Meaningful engagement with the relevant research population is expected (e.g., patients, caregivers, community organizations).
• Data and Safety Monitoring Plan is required for all clinical trials.
• Milestone Plan is required and future year support is contingent on satisfactory progress.

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External Links

• Full Funding Announcement (PAS-25-102)
• NIDDK Research Programs
• NIH How to Apply - Application Guide
• NIH Standard Due Dates
• NIH Data Management and Sharing Policy
• Research Methods Resources for Clinical Trials
• Apply via Grants.gov

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Contact Information

For additional contacts and details, see Section VII. Agency Contacts in the full announcement.