NIDDK Funding for Multi-Center Clinical Studies through Cooperative Agreements

May 2020 Council

Lead Division/Office

DEM, KUH, DDN

Point(s) of Contact

Barbara Linder, M.D., Ph.D.; Tracy Rankin, Ph.D., M.P.H.; Aynur Unalp-Arida M.D., M.Sc., Ph.D.

Executive Summary

NIDDK currently supports the funding of multi-center clinical studies through a U34 planning grant followed by a separate application for the clinical trial or study (U01). Multi-center clinical study proposals cannot be submitted as regular investigator-initiated R01s. However, some multicenter studies may not require extensive NIDDK programmatic involvement and could be conducted as R01s. The existing U34/U01 PARs will be expiring in the fall. NIDDK will reissue the U34/U01 PARs but will change its requirement to use these mechanisms from one based solely on the number of centers involved in a clinical study to a risk-based approach. Under the new NIDDK policy, investigators proposing to conduct low-risk multi-center clinical studies (e.g., that involve a behavioral intervention or use of an approved drug with a known and low risk safety profile) may now submit their applications as R01s under PA 18-330, PA-19-056, or other appropriate FOAs. Multi-center clinical studies (i.e., more than one center) that are considered high-risk will still be required to use the two-part, cooperative agreement process.