Quantitative imaging test approval and biomarker qualification: Interrelated but distinct activities

John Waterton, Andrew J. Buckler, Linda Bresolin, N. Reed Dunnick, Daniel C. Sullivan

    Research output: Contribution to journalArticlepeer-review

    Abstract

    Quantitative imaging biomarkers could speed the development of new treatments for unmet medical needs and improve routine clinical care. However, it is not clear how the various regulatory and nonregulatory (eg, reimbursement) processes (often referred to as pathways) relate, nor is it clear which data need to be collected to support these different pathways most efficiently, given the timeand cost-intensive nature of doing so. The purpose of this article is to describe current thinking regarding these pathways emerging from diverse stakeholders interested and active in the definition, validation, and qualification of quantitative imaging biomarkers and to propose processes to facilitate the development and use of quantitative imaging biomarkers. A flexible framework is described that may be adapted for each imaging application, providing mechanisms that can be used to develop, assess, and evaluate relevant biomarkers. From this framework, processes can be mapped that would be applicable to both imaging product development and to quantitative imaging biomarker development aimed at increasing the effectiveness and availability of quantitative imaging. © RSNA, 2011.
    Original languageEnglish
    Pages (from-to)875-884
    Number of pages9
    JournalRadiology
    Volume259
    Issue number3
    DOIs
    Publication statusPublished - Jun 2011

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