Core B: Biostatistics and Bioinformatics

CORE B: SUMMARY/ABSTRACT The Biostatistics and Bioinformatics Core’s primary goal is to collaborate with the P01 Investigators and other Core resource scientists to ensure that research conducted within the framework of this P01 program adheres to the highest standards of quality, rigor, and reproducibility. The overarching goal of this P01 is to develop a

precision medicine platform that enhances the personalization of breast cancer screening and prevention. This will be achieved through the application of subtype-specific risk assessment, risk-based screening, and risk reduction strategies. This ambitious initiative involves: Expanding the enrollment of the WISDOM 1.0 study to

an extended network and evaluating the performance of our subtype-specific risk predictors (WISDOM 2.0) in Project 1; Updating risk models by incorporating polygenic risk scores (PRS’), mammographic AI, and clinical factors to predict specific subtypes of breast cancers (fast vs. slow-growing) in Projects 2 and 3; Utilizing the

MISCAN (CISNET) model to estimate the long-term benefits, potential harms, and cost-effectiveness of both WISDOM 1.0 and 2.0. The BBC will serve as a centralized resource for comprehensive analytic, computational, and data management support to ensure the success of individual projects and the P01 as a

whole. It is committed to provide timely support tailored to the specific needs of each project and Core, using best practices and innovations in biostatistics/ bioinformatics/ machine learning/ data science. Administrative efficiency will be achieved through centralized task prioritization and milestone tracking. Cost effectiveness will

be achieved by leveraging existing expertise and infrastructure. Under Aim 2 (Providing Centralized Data Management) in accordance with NIH’s data sharing and privacy requirements and reproducible research principles, we will extend I-SPY 2’s cloud-based platform and incorporate WISDOM 1.0 data collection

infrastructure to establish a secure, integrated cloud-based platform for this P01. Comprehensive support will be provided across all phases of research endeavors, encompassing everything from shaping research inquiries to gathering, analyzing, interpreting data, and disseminating results. The specific nature of

collaboration will be fine-tuned to the unique scientific context and the distinct biostatistics, bioinformatics and data management needs of each project. Throughout the development of P01, Core personnel have engaged with project investigators individually, providing consultation on study design and analysis for proposed studies

in each program application.