NIDDK High Risk Multi-Center Clinical Study Cooperative Agreement (U01 Clinical Trial Required)
National Institutes of Health (NIH)
Funding amount is not limited but must reflect the actual needs of the proposed project.
Maximum project period is 5 years.
To support high-risk, multi-center clinical trials that are hypothesis-driven and focus on diseases relevant to the NIDDK mission.
Trials should have the potential to change clinical practice and/or public health.
Investigators and research teams conducting clinical trials.
Patients and communities affected by diabetes, digestive, and kidney diseases.
Eligible organization types include higher education institutions, nonprofits, for-profit organizations, small businesses, local, state, and federal governments.
Non-domestic entities (foreign organizations) are not eligible to apply.
Applications must be from organizations based in the U.S.
Non-domestic components of U.S. organizations are not eligible.
Projects must propose therapeutic clinical trials.
Planning activities must be completed prior to submission and are not permitted under this NOFO.
Application budgets are not limited but must reflect the actual needs of the proposed project.
Applications are due by 5:00 PM local time of the applicant organization.
Key dates include application due dates and review cycles.
The NIH will not accept duplicate or highly overlapping applications under review at the same time.
Applications must include a detailed study protocol, budget, and letters of support from clinical centers.
Applications will be evaluated based on significance, innovation, rigor, and feasibility.
Applications will undergo peer review and be evaluated for scientific and technical merit.
Applications that align with NIDDK's mission and priorities will be prioritized.
Engagement with community stakeholders is essential for the development and execution of the study.
Non-responsive applications will not be reviewed and will be withdrawn from consideration.
Consultation with NIDDK staff is encouraged to ensure alignment with the institute's mission.
Strong community engagement and a well-defined study protocol can enhance competitiveness.
Demonstrating substantial engagement with affected communities and stakeholders.
Submitting applications that do not comply with the specific instructions outlined in the NOFO.
Engage with NIDDK staff early in the application process to clarify expectations and requirements.
Highlight the potential impact of the proposed trial on clinical practice and public health.