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Advancing Imaging Biomarkers through Comprehensive Data Management and Regulatory Support

This project focuses on enhancing the understanding and development of imaging biomarkers by creating and managing reference data sets from both clinical and synthetic sources. We aim to conduct comparative evaluations against gold standards, measure the correlation of imaging biomarkers with clinical endpoints, and carry out compliance tests for supplier implementations. Additionally, we facilitate the formal registration of data with the FDA for qualification and approval, supporting experimental groundwork for marker development and algorithm discovery in quantitative imaging informatics.

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Advancing Imaging Biomarkers through Comprehensive Data Management and Regulatory Support

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  1. Sources Related activities to draw from / support: • CDER – CDRH pathways • QIBA testbeds • Open Image Archives ad hoc committee • Biochange • TCGA Radiology and other correlative in-silico studies • JANUS – SDTM • QIN • RVL • Legacy understanding of requirements from current version of tools Workflows (priority order): • Suite: • Create and manage reference data sets using clinical and synthetic data • Comparative evaluation vs. gold standards or otherwise accepted markers • Measure correlation of imaging biomarkers with clinical endpoints • Compliance tests / proficiency testing of supplier implementations • Formal registration of data with FDA for qualification (CDER) and approval or clearance (CDRH) • Support experimental groundwork for marker development • Support algorithm discovery and early development Informatics Services for Quantitative Imaging

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