This application responds to RFA-DE-05-006 for a General Dental Practice-Based Research Network, and is an application to serve as the Coordinating Center (CC) for the Practice-Based Research Network (PBRN) in the RFA. In conjunction with the proposed Network Chair, we have formed the """"""""Dental PBRN"""""""" that includes dentists from six US states and Scandinavia. We have a unique opportunity to build upon a statewide dental PBRN in Alabama which already has one NIH-funded R01 clinical trial and one NIH-funded R21 study in progress; and experience from large cross-sectional and longitudinal dental practice-based studies in Florida, Minnesota, the Pacific Northwest, and Scandinavia. Our application is best viewed as a joint response from the CC and the Network Chair-both groups must work as a fully-integrated entity. The Dental PBRN's primary scientific aims are to: (1) accelerate development and conduct of clinical research; (2) perform relatively short-term studies to compare effectiveness of preventive and treatment methods; and (3) strengthen the knowledge base for clinical decision making. Secondary aims are to: (1) conduct anonymous chart reviews; (2) provide data on treatment trends; and (3) estimate prevalence of less-common conditions. The Dental PBRN organizational structure comprises dental practices, the Network Chair administrative structure, the CC, the Executive Committee, the Protocol Review Committee, the Data & Safety Monitoring Board, the Observational Studies Monitoring Board, and NIDCR staff. We will assist the Network Chair and the Executive Committee to select practitioners to participate in specific studies and will organize protocol development, training procedures and materials and conduct training sessions. We will also establish and operate appropriate quality assurance programs assessing and monitoring practitioner performance and other key operational activities. We will adapt appropriate technology for data collection, data management and study analytical and publication issues. We will establish Safety and Data Management Boards and Observational Study Monitoring Boards for safety and ethical overview and will operate the IRB approval process for study protocols. This will include the creation and maintenance of a database documenting the consent process and any layers contained there. ? ? ?
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