Small R01s for Clinical Trials Targeting Diseases within the Mission of NIDDK (R01 Clinical Trial Required)
This grant funds small clinical trials targeting NIDDK diseases, seeking preliminary data to pave the way for larger trials to improve treatment and prevention.
Funder: National Institutes of Health
Due Dates: June 5, 2025 (New) | July 5, 2025 (Renewal/Resubmission/Revision) | September 7, 2025 (AIDS) | October 5, 2025 (New) | November 5, 2025 (Renewal/Resubmission/Revision) | January 7, 2026 (AIDS) | February 5, 2026 (New) | March 5, 2026 (Renewal/Resubmission/Revision) | May 7, 2026 (AIDS)
Funding Amounts: Up to $200,000 direct costs per year for up to 3 years (R01); total program intent is $1M/year for up to 3 awards beyond normal R01s.
Summary: Funds small, short-term clinical trials in humans to generate preliminary and feasibility data for future, larger trials on diseases within the NIDDK mission.
Key Information: Preliminary efficacy data are not required; only clinical trials (not observational studies) are eligible; contact NIDDK staff early to confirm fit.
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.
