Clinical Trials Program

NIDCR is committed to identifying effective preventive, diagnostic, and treatment approaches for dental, oral, and craniofacial diseases and disorders. To advance these efforts, the Institute supports well-designed and executed clinical trials (Phase I, II, III, and IV) that test interventions and have the potential to improve dental, oral, and craniofacial health. These trials should provide scientific evidence that can be used for establishing or changing the standard of care, or for consideration of a change in health care policy.

Because of the complexity and specific requirements pertaining to the conduct of clinical trials, extramural clinical trials within the mission of the NIDCR are submitted to specific funding announcements or certain trans-NIH FOAs that target specific areas of science of high interest to NIDCR. All NIDCR Funding Opportunity Announcements (FOAs) soliciting applications for clinical trials require specific elements so that the planning and implementation of the proposed clinical trial can be evaluated by reviewers and NIDCR.

As described in the NIDCR Policy on Applications for Investigator-Initiated Clinical Trials, NIDCR supports most investigator-initiated clinical trials through a phased, milestone-driven cooperative agreement mechanism. The UG3/UH3 mechanism supports clinical trials planning activities during a UG3 phase, followed by implementation of clinical trials during a UH3 phase. Investigators interested in conducting clinical trials testing a drug, biologic, device, or procedure relevant relevant to the mission of NIDCR should utilize Funding Opportunity Announcement “NIDCR Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required), PAR-21-160.” 

For clinical trials involving investigational products regulated by the FDA, the planning phase may also include final preparation of documents for submission in an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application. To be eligible for NIH funding, all clinical research involving investigational drugs, biologics, devices, or other products regulated by the FDA, must comply with all applicable FDA requirements. The grantee is responsible for ensuring compliance with FDA’s requirements and for informing NIDCR of significant communications with FDA, as described in the NIH Grants Policy Statement.

Studies designed to develop and test behavior change interventions related to dental, oral or craniofacial conditions should utilize the Funding Opportunity Announcement “NIDCR Behavioral and Social Intervention Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required), PAR-21-317. Investigators are strongly encouraged to contact Program Directors for guidance.

Any NIDCR-funded clinical trial must comply with NIDCR’s Clinical Terms of Award (CToA), which are incorporated into the Notice of Grant Award. Awardees subject to CToA are required to submit specific documentation and adhere to certain requirements prior to initiation of the clinical trial and throughout the lifecycle of the clinical trial.