Clinical Trials Program

The National Institute of Dental and Craniofacial Research (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 well-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 NIDCR are submitted to specific notices of funding opportunity (NOFOs) or certain trans-NIH NOFOs that target specific areas of science of high interest to NIDCR. All NIDCR NOFOs accepting 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 Guidance 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 trial planning activities during a UG3 phase, followed by implementation during a UH3 phase. Investigators interested in conducting clinical trials testing a drug, biologic, device, or procedure relevant to the mission of NIDCR should utilize the NOFO “NIDCR Drug, Biologic, Device and/or Procedure Intervention Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required),” PAR-25-057.

For clinical trials involving investigational products regulated by the U.S. Food and Drug Administration (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 awardee is responsible for ensuring compliance with FDA requirements and for informing NIDCR of significant communications with FDA, as described in the NIH Grants Policy Statement.

Studies designed to develop and test behavioral/biopsychosocial interventions related to dental, oral, or craniofacial conditions and associated medical and mental health comorbidities should utilize the NOFO “NIDCR Behavioral and Social Intervention Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required),” PAR-25-188. Investigators are strongly encouraged to contact program directors for guidance.

PAR-25-062, “Continuation or Revision of NIDCR Clinical Trial Planning and Implementation Cooperative Agreement (UH3 Clinical Trial Required),” will accept applications for competing renewal of ongoing clinical trials supported by NIDCR or competitive revisions proposing to modify the scope of ongoing NIDCR-supported clinical trials.

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.