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

Background
The Small R01s for Clinical Trials Targeting Diseases within the Mission of NIDDK (R01 Clinical Trial Required) is a funding opportunity issued by the National Institutes of Health (NIH), specifically through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

The goal of this grant is to encourage pilot and feasibility clinical trials in humans that will serve as a foundation for larger clinical trials aimed at preventing and treating diseases within NIDDK's mission. This includes a focus on improving health outcomes related to diabetes, digestive diseases, kidney diseases, and other related conditions. The program supports short-term proof-of-concept trials that can provide preliminary data on intervention effects and feasibility data regarding participant recruitment and study conduct.

Grant Details
The program supports small, short-term proof-of-concept clinical trials in humans to acquire preliminary data regarding intervention effects, feasibility data related to recruitment and retention, and study conduct. Applications must have clearly defined aims and objectives with a high likelihood of leading to more definitive, hypothesis-driven trials.

The funding opportunity emphasizes the importance of a Plan for Enhancing Diverse Perspectives (PEDP) which will be assessed during peer review. Eligible applications may propose either therapeutic or mechanistic clinical trials, including Basic Experimental Studies with Humans (BESH). The maximum project period is three years with direct costs limited to $200,000 per year.

Eligibility Requirements
Eligible applicants include higher education institutions (public or private), nonprofits, for-profit organizations (including small businesses), local governments, state governments, county governments, city or township governments, Indian/Native American tribal governments (federally recognized), federal agencies, U.S. territories or possessions, independent school districts, public housing authorities/Indian housing authorities, faith-based or community-based organizations, regional organizations.

Period of Performance
The maximum project period is three years.

Grant Value
NIDDK intends to commit $1 million in FY2025 to fund up to 3 awards beyond its normal R01 funding policies. Direct costs are limited to $200,000 per year.