Core B: Clinical Informatics & Analytics

ABSTRACT: CORE B (CLINICAL INFORMATICS & ANALYTICS) The central hypothesis of this proposed OPC-SURVIVOR P01 is to improve lifelong quality of life (QOL) and health among oropharyngeal cancer (OPC) survivors by uncovering novel phenotypes and trajectories and delivering non-invasive clinic-ready markers of delayed adverse treatment sequelae and novel mitigation

strategies. Three Projects are proposed, all of which require statistical support and timely collection, curation, management, and access to data related to the MD Anderson Oropharynx (MDA-OPC) and enrichment OPC cohorts. Core B will provide a centralized data infrastructure to facilitate data integration, and provide coordinated

analytic support for study design, data sharing, and data analysis across all Projects and Cores within the OPC- SURVIVOR Program. Objectives for Core B include: • Application of a novel oropharynx cancer-specific ontology across all Projects. • Build and optimize customized biomedical informatics pipelines for data extraction, processing, and storage.

• Data management and stewardship compliance with the data sharing policies set forth in the “Final NIH Policy for Data Management and Sharing.” • Build and oversee semi-automated, robust data quality control assessment protocols. • Build query-friendly, interactive clinical information visualization dashboards for preliminary data exploration

by the Project and Core teams. • Provide input on statistical design, sample size determination, analytical methods, and reporting for all projects and cores. • Build risk-models to predict short-term and long-term treatment-related toxicities by incorporating medical- demographic variables, patient reported outcomes, blood-based, image-based, and functional biomarkers.

• For clinical trials, Core B will ensure rigorous analysis following the analysis plan laid out in the clinical trial protocols. • Work with Core A (Administrative Core) on Data Governance. • Work with Core C (PROF Core) on the integrated Web-based database management system. This will facilitate prospective data collection, entry, quality control, integration, query, reporting, and data visualization

of data for all studies. • Practice methods of reproducible research and enhance study rigor. The work of Core B is significant as standardized capture of temporal outcomes for OPC survivors and effective knowledge representation will optimize the sustainability of the OPC-SURVIVOR Program while optimizing

health information exchange and event path planning for advanced computational modeling and characterization of cancer treatment-related adverse effects. The advanced statistical support also provided by Core B will ensure the successful completion of all proposed Projects.