Quantitative Imaging Test Approval and Biomarker Qualification: Interrelated but Distinct Activities
| Autor: | Lawrence H. Schwartz, Lisa Karam, Claus Bendtsen, Bernard Bendriem, Ronald Boellaard, Maryellen L. Giger, Gary S. Dorfman, Edward F. Jackson, Willy Eidsaunet, Brian Zimmerman, Mark A. Rosen, David E. Gustafson, Barry A. Siegel, Patricia E. Cole, Walter Wolf, Cathy Elsinger, Pamela S. Douglas, Haren Rupani, N. Reed Dunnick, Gary J. Kelloff, Geoffrey McLennan, Colin G Miller, Gudrun Zahlmann, Rick Patt, Sandeep N. Gupta, Richard L. Wahl, Keith E. Muller, Otto S. Hoekstra, James J Conklin, Andrew J. Buckler, David Raunig, John C. Waterton, Richard Frank, Hugo J.W.L. Aerts, John M. Boone, A. Gregory Sorensen, Daniel C. Sullivan, P. David Mozley, Constantine Gatsonis, Paul E. Kinahan, Linda B. Bresolin |
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| Přispěvatelé: | Radiology and nuclear medicine, CCA - Disease profiling, Radiotherapie, RS: GROW - School for Oncology and Reproduction |
| Jazyk: | angličtina |
| Rok vydání: | 2011 |
| Předmět: |
Diagnostic Imaging
Pathology medicine.medical_specialty Biomedical Research Technology Assessment Biomedical Process management Quantitative imaging Device Approval Conflict of Interest United States Food and Drug Administration business.industry United States Test (assessment) Europe Predictive Value of Tests Humans Medicine Biomarker (medicine) Radiology Nuclear Medicine and imaging Diffusion of Innovation business Biomarkers Original Research |
| Zdroj: | Radiology, 259(3), 875-884. Radiological Society of North America Inc. Radiology, 259(3), 875-884. Radiological Society of North America, Inc. Buckler, A J, Bresolin, L, Dunnick, N R, Sullivan, D C, Aerts, H J W L, Bendriem, B, Bendtsen, C, Boellaard, R, Boone, J M, Cole, P E, Conklin, J J, Dorfman, G S, Douglas, P S, Eidsaunet, W, Elsinger, C, Frank, R A, Gatsonis, C, Giger, M L, Gupta, S N, Gustafson, D, Hoekstra, O S, Jackson, E F, Karam, L, Kelloff, G J, Kinahan, P E, McLennan, G, Miller, C G, Mozley, P D, Muller, K E, Patt, R, Raunig, D, Rupani, H, Schwartz, L H, Siegel, B A, Sorensen, A G, Wahl, R L, Waterton, J C, Wolff, W, Zahlmann, G & Zimmerman, B 2011, ' Quantitative imaging test approval and biomarker qualification: interrelated but distinct activities ', Radiology, vol. 259, no. 3, pp. 875-884 . https://doi.org/10.1148/radiol.10100800 |
| ISSN: | 0033-8419 |
| DOI: | 10.1148/radiol.10100800 |
| Popis: | 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.http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.10100800/-/DC1.RSNA, 2011 |
| Databáze: | OpenAIRE |
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