Contact: Dr. Jane Atkinson, (301) 435-7908, jatkinso@mail.nih.gov
Because of their complexity and the evolving requirements pertaining to clinical trials, the Clinical Trials Program is the focal point for all extramural clinical trials within the mission of the NIDCR.
NIDCR Clinical Trials Program
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 has revised its clinical trials program to focus on the support of well-designed, definitive, multicenter Phase III clinical trials that will improve health and well-being. These trials should provide scientific evidence that can be used for consideration of a change in health policy or establishing or changing the standard of care. See more information on Clinical Trials.
The NIDCR has developed a process for investigators to use to determine NIDCR's programmatic interest in Phase III clinical trial ideas, the Clinical Trial Proposal Procedure. In addition, the NIDCR has developed two new funding mechanisms to assist investigators in developing the final Phase III trial. These funding mechanisms are the NIDCR Clinical Pilot Data Grant and the NIDCR Clinical Trial Planning Grant. The Clinical Pilot Data Grant provides a mechanism for the collection of preliminary data that is necessary to support the development of a definitive Phase III clinical trial. The Clinical Trial Planning Grant provides support to facilitate activities central to the refinement of the Phase III clinical trial protocol, for developing and implementing the organizational structures necessary to carry out the trial, and to develop the detailed Manual of Procedures required to guide the conduct of the clinical trial. Information about the Clinical Trial Proposal Procedure and the two grant mechanisms can be found at the web site listed above.
Each Phase III clinical trial supported by the NIDCR will be supported as a cooperative agreement which defines a partnership relationship between the clinical trial investigators and the NIDCR. The Terms and Conditions that describe this partnership relationship and under which a clinical trial cooperative agreement is made are presented on the NIDCR's clinical trials program web site at the URL listed above. Because of the unique nature of Phase III 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 are also listed on the clinical trials program web site.
Additional Information
For further information about the NIDCR Clinical Trials Program please contact:
Jane C. Atkinson, D.D.S.
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 information about the review of clinical trials applications please contact:
Lynn King, Ph.D.
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) 594-5006
Fax: (301) 480-8303
Email: Lynn.King@nih.gov
Updated January 28, 2008