Continuation or Revision of NIDCR Clinical Trial Implementation Cooperative Agreement (UH3 Clinical Trial Required)

The National Institute of Dental and Craniofacial Research (NIDCR) is offering funding through a cooperative agreement for the continuation or revision of ongoing clinical trials. This opportunity, titled "Continuation or Revision of NIDCR Clinical Trial Implementation Cooperative Agreement," aims to extend trials that require additional time or follow-up to complete long-term evaluations, or to modify the scope of existing trials based on emerging needs. Applicants may submit proposals for either competitive renewals (for time extensions) or competitive revisions (to expand trial scope), with the expectation that all trials should contribute robust data to inform clinical practices in dental, oral, and craniofacial health. Eligible applicants include institutions of higher education, government entities, nonprofits, for-profit organizations, tribal governments, and more. Notably, foreign institutions may not apply, although foreign components are permitted within U.S.-based applications. The FOA mandates strict adherence to guidelines outlined in the SF424 (R&R) Application Guide, with submissions allowed only through NIH’s ASSIST, institutional system-to-system solutions, or Grants.gov. All applications must be submitted electronically, and applicants are encouraged to submit letters of intent to help NIDCR anticipate review demands. Funding is available for trials focused on prevention, diagnostic, or treatment interventions for dental and craniofacial conditions, including FDA-regulated drugs and devices as well as behavioral and social interventions. Trials may include single-center or multi-center designs and should adhere to NIH’s clinical trial standards, including protocol registration and participant monitoring plans. NIDCR will collaborate actively with awardees to provide scientific guidance, ensure compliance, and oversee study milestones. The maximum project period is five years, and applications with a direct cost request exceeding $500,000 in any year require prior consultation with NIDCR staff. Applications must demonstrate clear significance, methodological rigor, and potential impact. The review process will prioritize trials that address critical health questions or unmet needs, particularly those with well-defined objectives, comprehensive recruitment and retention plans, and robust data management protocols. The FOA emphasizes a milestone-driven approach, with annual milestones serving as checkpoints to maintain progress. A milestone plan detailing recruitment benchmarks, study activations, and outcome evaluations must accompany the application to ensure efficient use of resources. For data handling, applications should include a Data Management and Sharing Plan, reflecting NIH’s recent policy changes on data transparency. Additional requirements include a Quality Management Plan to standardize trial protocols and address study adherence across sites, as well as a detailed statistical plan that accounts for any group-based interventions or missing data management. Clinical trial applicants must also ensure compliance with all applicable NIH policies on human subjects research and submit to oversight by NIH-designated review boards. Funding decisions will be based on scientific merit, available funds, and alignment with NIDCR’s strategic priorities. Applications undergo a two-step review process, beginning with NIH peer review, followed by advisory council assessment. Award recipients must register clinical trials in ClinicalTrials.gov and adhere to NIH policies on human subjects protection, data sharing, and trial reporting.