The overall goal of the proposed research project is to establish the Data Coordinating Center (DCC) for the Pacific Northwest Dental Practice Based Research Network (PNW/DPBRN). Both the DCC and the PNW/DPBRN will be based at the University of Washington School of Dentistry. The DCC will build on the strengths of an existing Biostatistics group that has a successful long-term track record in biostatistical methodologic research and collaboration in clinical dental research, as well as the expertise and extensive experience of Axio Research, a Contract Research Organization nearby in downtown Seattle. In response to RFA-DE-05-006 issued by the NIDCR, the DCC will provide the scientific leadership in design and implementation of clinical research and the infrastructure needed for the conduct of multiple clinical trials and prospective observational studies to address important oral health care questions.
Five specific aims will be achieved: 1) Establish the infrastructure and develop Standard Operating Procedures for the DCC;2) Create a reliable and customizable Web portal for commincations throughout the Network;3) Participate with the Network Chair in training programs;4) Assist Network members and Network Chair investigators in the design and initiation of at least 20 research studies, and ensure that IRB approvals are obtained before any patients are enrolled;and 5) Provide all biostatistical support for the implementation of approximately 20 approved research studies, including the coordination of the Data and Safety Monitoring Board.
These specific aims will be achieved by a team of investigators with complementary sets of expertise and experience. The Director of the DCC will be Dr. Brian Leroux, who currently leads a large active Biostatistics group at the University of Washington School of Dentistry. Key roles will be played by Dr. Lloyd Mancl, in Biostatistics, Dr. Philippe Hujoel, in Epidemiology and Study Design, and Jeffrey Sherman, in Behavioral Science, all at the University of Washington. The Data Management and IT Support Unit will be led by Ms. Ruth McBride, who has extensive experience managing coordinating centers for major NIHsponsored clinical trials in cardiovascular and pulmonary diseases, as well as industry-sponsored trials in a variety of clinical disease areas. Together, these investigators have the necessary expertise and experience in all areas that are critical for the success of the Data Coordinating Center for support of clinical dental research in the Pacific Northwest Dental Practice Based Research Network
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