Clinical Trials Program

NIDCR is committed to identifying effective preventive, diagnostic, and treatment approaches for craniofacial, oral, and dental diseases and disorders. To advance these efforts, the Institute supports well-designed clinical trials (Phase I, II, III, and IV) that have the potential to improve 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. NIDCR does not accept clinical trial applications through "parent" FOA announcements. 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 two-part process: (1) a planning phase followed by (2) a trial implementation phase. Investigators interested in conducting clinical trials 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-18-547.” However, studies designed to test the efficacy of a behavioral intervention will be supported by a separate Funding Opportunity Announcement. Investigators are strongly encouraged to contact Program Directors for guidance.

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 and 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.

Any NIDCR-funded clinical trial must comply with NIDCR’s Clinical Terms of Award (CToA), which are incorporated into the Notice of Grant Award (NGA). 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.

Last Reviewed
May 2020