The Small R01s for Clinical Trials Targeting Diseases within the Mission of NIDDK (R01 Clinical Trial Required) funding opportunity is designed to support small-scale pilot and feasibility clinical trials. These grants are intended to lay the groundwork for larger, hypothesis-driven studies that aim to improve the prevention, diagnosis, or treatment of diseases falling under the mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The program emphasizes acquiring preliminary data on intervention effects, feasibility data related to recruitment and retention, and addressing operational issues to facilitate future definitive trials.

Eligible projects include proof-of-concept clinical trials in humans to assess intervention feasibility and trends in efficacy. These trials should have clearly defined aims and a high likelihood of leading to larger studies. Priority is given to projects with innovative approaches, significant public health relevance, and those addressing health disparities. Applications must include a Plan for Enhancing Diverse Perspectives (PEDP), which will be evaluated during peer review.

The maximum project period is three years, with direct costs capped at $200,000 annually. NIDDK anticipates funding up to three awards, depending on the availability of appropriations and the number of meritorious applications. Eligible applicants include higher education institutions, nonprofits, for-profit entities, local and tribal governments, and other organizations within the United States. Foreign components are allowed to provide scientific input but cannot recruit participants.

Applications must be submitted electronically via Grants.gov, following NIH’s standard submission and formatting guidelines. The PEDP must outline actionable strategies to enhance inclusivity and diverse perspectives in the research process. Key considerations include collaboration with underrepresented groups and community-based organizations and ensuring diverse representation among trial participants.

Applications will be reviewed based on factors including the significance of the research, scientific rigor, feasibility, innovation, investigator expertise, and alignment with NIDDK priorities. Post-award requirements include annual Research Performance Progress Reports (RPPRs) and adherence to data management and sharing policies. Important deadlines include application due dates of February 5, June 5, and October 5 annually until the expiration date of May 8, 2026.

Potential applicants are encouraged to consult NIDDK staff early in the application process to ensure alignment with program goals. Additional support for submission and inquiries is available from NIH contacts listed in the funding announcement.