NIDDK High Risk Multi-Center Clinical Study Cooperative Agreement (U01 Clinical Trial Required)
Funding for high-risk multi-center clinical trials aiming to change clinical practice in NIDDK-relevant diseases; planning activities not allowed.
This grant is no longer accepting proposals
National Institutes of Health has archived this opportunity.
Funder: National Institutes of Health
Due Dates: February 5, 2025 (New) | March 5, 2025 (Renewal/Resubmission/Revision) | June 5, 2025 (New) | July 5, 2025 (Renewal/Resubmission/Revision) | October 5, 2025 (New) | November 5, 2025 (Renewal/Resubmission/Revision) | January 28, 2026 (Final closing/expiration)
Funding Amounts: No set budget limit; budgets should reflect project needs; max project period is 5 years.
Summary: Supports investigator-initiated, high-risk multi-center therapeutic clinical trials relevant to NIDDK’s mission, aiming to change clinical practice and/or public health.
Key Information: Planning activities must be completed prior to application; consult NIDDK staff before applying.
Description
This funding opportunity supports investigator-initiated, high-risk multi-center therapeutic clinical trials involving more than one clinical center, targeting diseases relevant to the mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The trials must be hypothesis-driven, have the potential to change clinical practice or public health, and focus on NIDDK mission areas such as diabetes, endocrine/metabolic diseases, digestive diseases, nutritional disorders, obesity, kidney, urologic, and hematologic diseases. Only therapeutic clinical trials (not mechanistic or observational studies) are supported.
Applicants are required to have completed all planning activities—such as protocol finalization, data management tools, and IRB initiation—prior to submission. If a planning phase is needed, applicants should first apply for a U34 implementation planning cooperative agreement. Consultation with NIDDK program staff is strongly encouraged before submission to confirm eligibility and appropriateness of the proposal.
