CORE--BIOSTATISTICAL AND CLINICAL SUPPORT

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We propose to Support Core to efficiently coordinate both fiscal and human resources, as well as to optimize utilization of equipment and facilities for Center research. The Support Core has three sections: A) Administrative; B) Biostatistics; and C) Clinical, and will be under the general direction of Dr. Robert J. Genco. Dr. Sara Grossi will serve as Co-Director of the Clinical support section, and Dr. Gary Koch will be the statistical consultant for the Biostatistics section. The purpose of the Administrative support section is to provide scientific leadership, managerial, and clerical support for the Periodontal Disease Research Center. Preparation, internal review, and tracking of manuscripts will be carried out with the assistance of the Administrative support section staff. They will also schedule, provide minutes of meetings of the Internal Advisory Committee and Center staff at which consensus on protocols and publications is achieved. The Administrative support section will be responsible for interactions of the Center with the University, granting agencies, and other institutions. It will also aid in the training and faculty development activities of the Center, as well as activities of the External Advisory Committee. This Committee, which is comprised of a consultant from each project, will conduct reviews of the Center, including a full review in the third year, which will be used to strengthen and refocus ongoing projects. The Biostatistics support section will advise on all aspects of protocol design, data management, and data analysis in which statistical methods and computer recordings or analysis is involved. Our Biometrics Group has participated effectively in clinical periodontal studies and related laboratory studies requiring data capture and management, and computer- assisted statistical analysis of large data bases generated by Center scientists. The Clinical support section will provide overall resources and facilities for human clinical studies including (1) training and calibration of examiners; (2) assistance in protocol design; (3) clinical operations manual preparation; (4) quality control of measurements during studies; (5) coordination of human experimentation committee review; (6) recruitment and maintenance of an active patient base of adults (Prospective Study Group), juveniles (LJP Registry), and other groups of subjects or controls as needed; (7) screening patients for studies based upon inclusion/exclusion criteria; (8) implementing and monitoring compliance with clinical protocols; (9) patient record management including ensuring confidentiality; and (10) implementing animal model studies. The Clinical support section personnel will also plan and coordinate patient dental and medical treatments not directly related to protocol procedures, but necessary for full management of patients in the clinical studies. Further, the Clinical support section will aid in developing and refining new diagnostic, clinical and radiographic measurements technologies. The Clinical support section will assist in the clinical aspects of all Center projects supported by this grant, the University, or other sources.