Quantitative imaging test approval and biomarker qualification: interrelated but distinct activities.


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.





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Publication Info

Buckler, Andrew J, Linda Bresolin, N Reed Dunnick, Daniel C Sullivan, Hugo JWL Aerts, Bernard Bendriem, Claus Bendtsen, Ronald Boellaard, et al. (2011). Quantitative imaging test approval and biomarker qualification: interrelated but distinct activities. Radiology, 259(3). pp. 875–884. 10.1148/radiol.10100800 Retrieved from https://hdl.handle.net/10161/21870.

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Daniel Carl Sullivan

Professor Emeritus of Radiology

Research interests are in oncologic imaging, especially the clinical evaluation and validation of imaging biomarkers for therapeutic response assessment.


Pamela Susan Douglas

Ursula Geller Distinguished Professor of Research in Cardiovascular Diseases

Pamela S Douglas MD is the Ursula Geller Professor of Research in Cardiovascular Diseases in the Department of Medicine at Duke University and Director of the Multimodality Imaging Program at Duke Clinical Research Institute. During her 30+ years of experience she has led several landmark multicenter government studies and pivotal industry clinical trials along with outcomes research studies.  She is renowned for her scientific and policy work in improving the quality and appropriateness of imaging in clinical care, clinical trials and registries and through development and dissemination of national standards for imaging utilization, informatics and analysis. She has been among the pioneers in a number of areas including heart disease in women, sports cardiology, and cardio-oncology. Dr. Douglas’ wealth of experience includes authorship of over 400 peer reviewed manuscripts and 30 practice guidelines, and service as the President of the American College of Cardiology, President of the American Society of Echocardiography, and Chief of Cardiology at both the University of Wisconsin and Duke University. She has also previously served on the faculties of the University of Pennsylvania and Harvard University. She currently serves on the External Advisory Council of the National Heart, Lung and Blood Institute and the Scientific Advisory Board of the Patient Advocate Foundation.

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