1. Quantitative imaging test approval and biomarker qualification: interrelated but distinct activities.
- Author
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Buckler AJ, Bresolin L, Dunnick NR, Sullivan DC, Aerts HJ, Bendriem B, Bendtsen C, Boellaard R, Boone JM, Cole PE, Conklin JJ, Dorfman GS, Douglas PS, Eidsaunet W, Elsinger C, Frank RA, Gatsonis C, Giger ML, Gupta SN, Gustafson D, Hoekstra OS, Jackson EF, Karam L, Kelloff GJ, Kinahan PE, McLennan G, Miller CG, Mozley PD, Muller KE, Patt R, Raunig D, Rosen M, Rupani H, Schwartz LH, Siegel BA, Sorensen AG, Wahl RL, Waterton JC, Wolf W, Zahlmann G, and Zimmerman B
- Subjects
- Biomedical Research organization & administration, Conflict of Interest, Device Approval, Europe, Humans, Predictive Value of Tests, United States, United States Food and Drug Administration, Biomarkers, Diagnostic Imaging, Diffusion of Innovation, Technology Assessment, Biomedical standards
- Abstract
Unlabelled: 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 time- and 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., Supplemental Material: http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.10100800/-/DC1., (RSNA, 2011)
- Published
- 2011
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