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Clinical Trials Program

Contact: Dr. Jane Atkinson, (301) 435-7908, jatkinso@mail.nih.gov

Because of the complexity of clinical research and the specific requirements pertaining to clinical trials, the Clinical Trials Program is the focal point for all extramural clinical trials within the mission of the NIDCR.

The 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.  Biomarker clinical evaluation studies are an integral part of the biomarker and diagnostics development pathway.  They are similar to clinical trials in that they are time-consuming, labor-intensive, complex, and costly.  As such, NIDCR will consider these studies to be logistically equivalent to clinical trials and subject to the same peer review and funding policies as investigator-initiated clinical trials submitted for NIDCR funding.  See more information on Clinical Trials and Biomarker Clinical Evaluation Studies.

The NIDCR will support investigator-initiated clinical trials and biomarker clinical evaluation studies exclusively through a two-part grant process: (1) a Clinical Trial or Biomarker Clinical Evaluation Study Planning Grant (R34), followed by (2) a Clinical Trial Implementation or Biomarker Clinical Evaluation Study Cooperative Agreement (U01).  The Clinical Trial or Biomarker Clinical Evaluation Study Planning Grant (R34) supports the comprehensive planning, design and documentation of investigator-initiated Phase I, II, III or IV interventional clinical trials or biomarker clinical evaluation studies.  Interventional behavioral studies, sometimes referred to as Stage I, II, III or IV studies, are included.  The R34 planning grant is designed to:  (1) permit early peer review of the rationale for the proposed clinical trial or biomarker clinical evaluation study; (2) permit early assessment of the design and implementation plans of the proposed trial or study; and (3) provide support for the development of a comprehensive clinical trial protocol or biomarker clinical evaluation protocol and associated documents, including a Manual of Procedures.  The complete protocol and associated documents are required components of any subsequent clinical trial implementation (U01) application.  For clinical trials involving investigational products regulated by the FDA, the R34 Planning Grant may also include 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.

Implementation of any clinical trial or biomarker clinical evaluation study funded by the NIDCR will be supported through the Clinical Trial Implementation or Biomarker Clinical Evaluation Study Cooperative Agreement (U01).  The U01 cooperative agreement establishes a partnership relationship between the clinical trial investigators and the NIDCR.  The Terms and Conditions that describe this partnership relationship are presented in the U01 announcement.  Because of the unique nature of clinical trials and the different components that comprise the organizational structure of the clinical trial, the NIDCR developed specific peer review criteria for each component.  These criteria are described in the funding opportunity announcements.  Applicants requesting $500,000 or more in direct costs in any year must seek agreement from NIDCR program staff at least 6 weeks before submitting the U01 application.

Related links and policies

Additional Information


For further information about the NIDCR Clinical Trials Program, please contact:

photo of Dr. Jane Atkinson

Jane C. Atkinson, DDS
Program Director, Clinical Trials Program
Center for Clinical Research
Division of Extramural Research
National Institute of Dental and Craniofacial Research
6701 Democracy Blvd. Room 634, Mail Stop 4878
Bethesda, MD  20892-4878
Telephone: (301) 435-7908
Email: jatkinso@mail.nih.gov

For questions about protocol templates or regulatory issues for a clinical trial application, please contact:

Mary A. Cutting, MS, RAC
Health Specialist, Center for Clinical Research
National Institute of Dental and Craniofacial Research
6701 Democracy Blvd., Rm. 630, Mail Stop 4878
Bethesda MD 20892-4878
Telephone: (301) 594-5391
Email: cuttingma@mail.nih.gov

For information about the review of clinical trials applications, please contact:

D. Yasaman Shirazi, PhD
Chief, Scientific Review Branch
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
6701 Democracy Blvd.
Room 662, Mail Stop 4878
Bethesda, MD  20892-4878
Telephone: (301) 594-5593
Fax: (301) 480-8303
Email: shiraziy@mail.nih.gov

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This page last updated: January 06, 2014