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 definitive, multicenter Phase III clinical trials. These trials provide scientific evidence for consideration of a change in health policy or standard of care. The following information will be useful to investigators in preparing and submitting applications for a Phase III clinical trial.

• NIDCR's New Clinical Trials Program
• Flowchart of Options for Submitting Clinical Trial Applications
• NIDCR'S Clinical Trial Proposal Procedure
• NIDCR Clinical Trial Planning Grant
• NIDCR Clinical Pilot Data Grant
• Sample Manual of Procedures (MOP) table of contents and outline (PDF: 571KB ) 
  (Also available in MS Word  and RTF formats)
  • Actual Example of a MOP Developed for a Phase III NIDCR Clinical Trial
    (courtesy of University of Minnesota/OPT Investigation Group)
• Review Criteria
  • Administrative Center/Chair
  • Clinical Centers
  • Data Coordinating Center
  • Laboratory/Testing Centers
• Data and Safety Monitoring Guidelines
• Cooperative Agreement Terms and Conditions for Clinical Trials

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

Dr. Bruce L. Pihlstrom
Acting Director
Division of Clinical Research and Health Promotion
National Institute of Dental and Craniofacial Research
Building 45, Room 4AS-43H
45 Center Drive, MSC 6401
Bethesda, MD 20892-6401
Telephone: (301) 594-4848
Fax: (301) 480-8322
Email: Bruce.Pihlstrom@nih.gov

Dr. Richard L. Mowery
Chief
Clinical, Epidemiology and Behavioral Research Branch
Division of Clinical Research and Health Promotion
National Institute of Dental and Craniofacial Research
Building 45, Room 4AS-43F
45 Center Drive, MSC 6401
Bethesda, MD 20892-6401
Telephone: (301) 594-4848
Fax: (301) 480-8322
Email: Richard.Mowery@nih.gov