AppalTRuST Biostatistics and Informatics Core

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ABSTRACT – BIOSTATISTICS AND INFORMATICS CORE The Biostatistics and Informatics Core (BIC) will serve as the AppalTRuST hub for study design and all data- related activities, including data collection, linkage, harmonization, analysis, sharing, and security. The core will include biostatistics and informatics experts and staff with extensive experience developing surveys, managing and analyzing data, and ensuring ongoing data security. Leveraging technology resources available through UK Markey Cancer Center, BIC will house all the biostatistical and informatics resources and expertise needed to support AppalTRuST projects and respond to additional needs arising from future TCORS priorities. BIC Aims include: (1) support the statistical planning and analysis, data collection, and data coordination needs of the AppalTRuST projects and cores; (2) collaborate with the Community Outreach & Participant Engagement (COPE) Core to develop data collection instruments harmonized across projects and data collection timelines; (3) create a secure, standardized, and integrated AppalTRuST Data Warehouse; and (4) Provide easy-to-use tools to ensure stakeholder access to the AppalTRuST Data Warehouse and other Center information. BIC will oversee and coordinate all aspects of research design as well as data collection, harmonization, and analyses for all projects and pilots. Data files, including structured, semi-structured, and unstructured data, along with data dictionaries and other documentation, will be managed centrally for projects, pilots, and cores in BIC. To facilitate the generalizability of inferential statistical analyses, BIC will also develop survey weights for all participants recruited to the AppalTRuST cohort. In collaboration with COPE, BIC will assist each project and pilot with coordinated development of data collection instruments to support seamless data sharing, limiting response burden for participants enrolled in more than one project and promoting synergy throughout the Center. BIC will also deploy informatics portals and reporting mechanisms to make data widely accessible to stakeholders, with users able to access only the data they have been authorized for, commensurate with their needs. The informatics portal will include dashboards, and analytical and query tools, which can be customized to coincide with the level of stakeholder data access needed. State-of-the-art analytical methods and information science will support and permeate all projects, pilots, and cores within AppalTRuST to ensure that the TCORS successfully meets its goal of investigating FDA CTP regulatory priorities in Appalachian Kentucky through collaboration, education, and pioneering regulatory science research.