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NIH clinical Trial Planning Grant

NIDCR CLINICAL TRIAL PLANNING GRANT Release Date: August 23, 1999 (see replacement PAR-03-042) PA NUMBER: PAR-99-157 National Institute of Dental and Craniofacial Research THIS PA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA. PURPOSE The National Institute of Dental and Craniofacial Research (NIDCR) is committed to identifying effective preventive, diagnostic and treatment approaches to craniofacial, oral and dental diseases and disorders that will improve health by supporting well-executed clinical trials. Clinical trials in one of the following five scientific areas are encouraged and sought: Inherited Craniofacial Diseases and Injury; Infectious Diseases; Neoplastic Diseases of the Head and Neck; Chronic Disabling Diseases including pain conditions, temporomandibular joint diseases, autoimmune diseases, and bone diseases; and Biomimetics, Tissue Engineering and Biomaterials. The National Cancer Institute also has an active interest in clinical trials related to head and neck neoplasms and may also fund planning grants in this area. The NIDCR is also interested in supporting clinical trials aimed at evaluating interventions that can have their effect on other systemic conditions (e.g., preterm low birthweight babies, cardiovascular disease) through prevention, diagnosis or treatment of craniofacial, oral or dental conditions (e.g., oral infections) and promotion of craniofacial, oral and dental health. Before proceeding to a full-scale randomized clinical trial, significant planning is often required. The NIDCR Clinical Trial Planning Grant allows for early peer review of the rationale and design of clinical trials of interventions aimed at preventing or treating diseases and provides support for the development of a detailed clinical trial research plan, including a complete field-tested manual of operations and procedures. Since many of the craniofacial, oral and dental diseases and disorders for which clinical interventions are designed to occur in scattered populations, the planning grant can also be useful in supporting the development of clinical trial research networks to develop multi-center clinical trials. HEALTHY PEOPLE...

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