NIDDK High Risk Multi-Center Clinical Study Cooperative Agreement (U01 Clinical Trial Required)

This NOFO invites applications for investigator-initiated, high-risk multi-center clinical trials involving more than one clinical center. Proposed trials should be hypothesis-driven, have the potential to change clinical practice and/or public health, and focus on a disease relevant to the mission of NIDDK. Planning activities must be completed prior to submission and are not permitted under this NOFO. Applicants who require a planning phase may first apply for an implementation planning cooperative agreement (U34; see PAR-24-094). Consultation with NIDDK Scientific/Research staff is strongly encouraged prior to the submission of either a U34 or U01 application.

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn.

Key Dates

Open Date: 1/5/2024

Letter of Intent Due Date: 30 days prior to application due date