The Biostatistics and Exposure Core will provide an integrated approach to all projects with regard to 1) study design, 2) biostatistical analysis, 3) data management and informatics, and 4) exposure assessment. By centralizing these activities, this multidisciplinary Core will boost the level of interaction among the projects and between projects and the Core. It will allow us to coordinate study design and data management issues, leading to a more coherent approach to exposure assessment and data analysis as well as significant cost savings. The Core Director (Fingeriin) and Co-Director, exposure assessment liaison (Martyny) will supervise a team experienced in conducting studies and coordinating multidisciplinary teams in clinical research. The team has the skill set required to manage complex issues of study design, epidemiology, genetics, quantitative methods, data management and exposure assessment. Interaction with Projects and Cores: The Biostatistics and Exposure Core will service all three projects. All projects will receive assistance with study design from the Core including consultation with project Pis on methodological issues, at the initiation of a study, and ongoing consultation as the study progresses. All three projects will also be served by the Core's biostatistical analysis responsibilities by: 1) meeting with Project Leaders to determine analysis needs, 2) conducting the analysis through the Core statistics team, Drs. Fingeriin and Strand and Ms. Silveira, for all three Projects, and directing the statistical analysis of genetic association studies for Project 2, and 3) assisting in the development of specialized models for data in Project 3. The Core's Data Management and Informatics responsibilities will extend to all three projects as well as the Administrative and Clinical Laboratory Cores including: 1) management of data acquisition and transfer, 2) development and maintenance of research databases, 3) ensuring data backup, storage, and security. The Exposure Assessment responsibilities of the Core will primarily serve Projects 2 and 3 including: 1) exposure interviews for new cohort members, 2) acquisition, analysis, and management of industrial hygiene monitoring data for NJH cohort employers, 3) collaboration with investigators responsible for other cohorts to develop consistent exposure assessment methods 4) development of uniform exposure metric across all cohorts to be used in this POI. The Biostatistics and Exposure Core will interact with the Administrative Core, as it provides the administrative and organizational structure to support this grant. This Core will receive direction from the Administrative, the Executive Committee, and Clinical Laboratory Cores at monthly meetings ofthe PI, Co-PI and Project Leaders, and provide reports on its activities as needed.

Public Health Relevance

The reason why some workers develop sensitization or disease when exposed to beryllium while others do not, is likely related to genetic and exposure factors, acting in concert to determine disease risk. This core provides the biostatistical and exposure resources necessary to analyze the genetic, exposure, and immunological factors important for all three projects in this POI. These analyses and exposure assessments will clarify the immunologic and exposure-disease relationships, and will have public health implications in the understanding of this and other environmental diseases.

National Institute of Health (NIH)
National Institute of Environmental Health Sciences (NIEHS)
Research Program Projects (P01)
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Special Emphasis Panel (ZES1-TN-J)
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University of Colorado Denver
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