The National Institute of Dental and Craniofacial Research (NIDCR) will require eight weeks to review Clinical Trial Planning Grant (R34) application submission requests. Please consider this when constructing the grant application submission timeline. An approval letter from NIDCR must be included with the application package.
The written request for approval must be no longer than 4 pages (Arial 11 pt font; 0.5 inch margins). The details included in the letter may vary depending on the type of study planned (e.g., Phase I, II, III or IV interventional study) and must address the following items:
- Anticipated date of submission.
- Study title.
- Study PI(s).
- Primary institution.
- Potential collaborating sites and their location.
- Phase of the proposed study, e.g., Phase I or Phase II.
- Study objective or objectives.
- Rationale:
--Scientific basis for and clinical significance of the proposed clinical trial.
--Potential impact on public health.
--Comparison with competitive therapies and degree of similarity with other clinical trials.
--Relevance to outcomes desired by the target patient population.
- Study design or flow diagram depicting study.
- Proposed study population.
- Estimated sample size.
- Feasibility to successfully undertake the study.
- Product to be evaluated and how it will be obtained.
- Industry partner, if applicable.
- Brief summary of risk information, e.g., available safety data for the product, such as the product label. Also, include a description of regulatory issues that have/need to be resolved, e.g. have IND/need IND.
- General statistical assumptions for the proposed study design and analysis.
- Identification and brief description of the Data Coordinating Center if the NIDCR Clinical Research Operations and Management Support contract is not used.
- Milestones to be accomplished during the R34.
- Total cost for the R34 phase.
- Total cost estimate of the clinical trial, not the planning grant, by year.
- Estimated start date, duration, and timeline of the clinical trial.
Submit requests electronically to:
Jane C. Atkinson, D.D.S.
Program Director, Clinical Trials Program
National Institute of Dental and Craniofacial Research
6701 Democracy Blvd., Room 634
MSC 4878
Bethesda, Maryland 20892-4878
Phone: (301) 435-7908
FAX: (301) 480-8322
email: jatkinso@mail.nih.gov