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Radiology. 2015 Dec;277(3):813-25. doi: 10.1148/radiol.2015142202. Epub 2015 Aug 12.

Metrology Standards for Quantitative Imaging Biomarkers.

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From the Department of Radiology, Duke University Medical Center, Box 2715, Durham, NC 27710 (D.C.S., D.P.B.); Department of Quantitative Health Sciences, Cleveland Clinic Foundation, Cleveland, Ohio (N.A.O.); Department of Public Health, University of Washington, Seattle, Wash (L.G.K.); Department of Informatics, ICON Medical, Washington, Pa (D.L.R.); Center for Statistical Sciences, Brown University, Providence, RI (C.G.); National Cancer Institute, Bethesda, Md (E.P.H., L.M.M.); Center for Devices and Radiological Health, U.S. Food and Drug Administration, White Oak, Md (M.K.); Department of Electrical and Computer Engineering, Cornell University, Ithaca, NY (A.P.R.); Department of Radiology, Oregon Health & Science University, Portland, Ore (A.R.G.); and Mallinckrodt Institute of Radiology, Washington University School of Medicine, St Louis, Mo (R.L.W.).


Although investigators in the imaging community have been active in developing and evaluating quantitative imaging biomarkers (QIBs), the development and implementation of QIBs have been hampered by the inconsistent or incorrect use of terminology or methods for technical performance and statistical concepts. Technical performance is an assessment of how a test performs in reference objects or subjects under controlled conditions. In this article, some of the relevant statistical concepts are reviewed, methods that can be used for evaluating and comparing QIBs are described, and some of the technical performance issues related to imaging biomarkers are discussed. More consistent and correct use of terminology and study design principles will improve clinical research, advance regulatory science, and foster better care for patients who undergo imaging studies.

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