Core C: Biometrics

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Abstract The Biometrics Core provides the infrastructure that facilitates an organized, synergistic, and centralized approach to statistics in HIV research for the UW/Fred Hutch CFAR members, with an emphasis on providing support and training to junior investigators. The services provided by the Core help ensure rigor and reproducibility in HIV research conducted by CFAR investigators. In addition to standard statistical support, the Core provides advanced statistical methods and expertise in the design, conduct and analysis of clinical research and laboratory studies to CFAR investigators. This includes the development of novel methods when standard approaches are not adequate or optimal by providing a crucial link between CFAR biomedical researchers and the large number of biostatistics and other quantitative sciences faculty at the University of Washington and the Fred Hutch who are developing new methods for HIV research. In addition, the CFAR clinical, behavioral, and laboratory researchers using the Core provide datasets for analysis, which motivate the development of new quantitative methods by biostatisticians, biomathematicians and bioinformaticists at UW and Fred Hutch. Hence, this link benefits CFAR members as well as academic quantitative science researchers. Finally, the Core provides training in both standard statistical methods as well as more advanced topics involving specialized method for complex new data types and provides an opportunity for the next generation of quantitative researchers and leaders. Specifically, methods for both microbiome analysis and viral dynamics studies are not well established so that results from analysis using standard methods are far from rigorous and reproducible. Thus the need for further methods development in this area is crucial. Finally, the quantitative support we provide contributes to the innovative, impactful, multidisciplinary and global research of all members who collaborate with our Core. To promote and facilitate these multidisciplinary interactions, the Biometrics Core: i) provides statistical, mathematical and informatics collaboration and consultation on study design, forms design, evaluation and pre-testing, data analysis, interpretation and reporting; coordinates Data Safety and Monitoring Boards; provides data management services (Aim 1); ii) serves as a liaison between the Core user with advanced quantitative needs and experts from the UW Departments of Biostatistics, Statistics, Mathematics, and Applied Mathematics, and the Fred Hutch Program in Biostatistics and Biomathematics (Aims 1 and 2); 3) develops, adapts and/or implements new or novel statistical and mathematical methods as dictated by the needs of CFAR members and their projects (Aim 2); 4) sponsors and conducts training activities designed to disseminate statistical skills to CFAR investigators, inform the HIV researchers about services available from the Biometrics Core, and introduce novel quantitative approaches to the UW/ Fred Hutch CFAR community (Aim 3); and 5) organizes activities that promote communication among existing statisticians in HIV research and interest from other biostatisticians that can be recruited to meet the growing demand of HIV research (All Aims).