The objective of this proposal is to improve the quality of dental clinical research in the United States by creating a regional facility linking Forsyth Dental Center, Harvard School of Dental Medicine, Boston University and Tufts University. The center will provide a variety of services designed to meet his objective. The educational objective will be accomplished by offering courses in the design and conduct of clinical trials in dentistry. These courses will include elements of experimental design, statistical analysis, and emphasize experimental conduct under FDA guidelines. Advanced statistical consultation will be provided to evaluate experimental designs, ensure appropriate experimental controls and propose new analytical proposals based on studies conducted within a Statistical Colloquium of regional statisticians. Subject acquisition will be through an intensive program of advertisement and cataloging of patients willing and interested in participating in clinical trials from each of the 4 Boston area dental institutions. The communication objective will be achieved through the Forsyth internet node. This facility will provide all dental investigators access to specific data bases initially including clinical data sets and DNA sequences of oral microorganisms.. It will also provide regional access for electronic mail and access to worldwide advanced Internet functions. Ongoing clinical trials within the clinical core center will offer an opportunity for interested individuals to obtain direct practical experience in the conduct of clinical trials. The center will solicit clinical studies to expand the relevance of NIDR funded laboratory studies, clinical studies of commercial products and directly support clinical studies funded through a pilot project program. Studies will be conducted under strict FDA guidelines ensuring confidentiality, quality and integrity through internal audit procedures. Advanced laboratory methodology will be made available as a service to assist in the conduct of clinical trials. The first such technology to be made available will be the """"""""checkerboard"""""""" DNA probe analysis for detection or oral microorganisms as part of clinical trials. A clinical pilot trials program will be initiated by which investigators of the Boston area may apply for support of pilot studies. Submissions will be reviewed by a panel of clinical scientists from all 4 Boston dental institutions and awarded according to priority assigned. A panel of external review members will be constituted to review and make recommendation concerning the activities of the clinical core center. Facilities available for clinical research at Forsyth will include a 10-chair operatory, a radiography facility, waiting room, data analysis facility, Internet linkage and clinical administration office.
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