Metrology Standards for Quantitative Imaging Biomarkers.


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.





Published Version (Please cite this version)


Publication Info

Sullivan, Daniel C, Nancy A Obuchowski, Larry G Kessler, David L Raunig, Constantine Gatsonis, Erich P Huang, Marina Kondratovich, Lisa M McShane, et al. (2015). Metrology Standards for Quantitative Imaging Biomarkers. Radiology, 277(3). pp. 813–825. 10.1148/radiol.2015142202 Retrieved from

This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.



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.


Daniel P. Barboriak

Professor of Radiology

(1) MR Imaging in Neuro-oncology. (2) MR Perfusion Imaging for quantitation of blood volume and permeability. (3) MR Diffusion Imaging. (4) Image Processing for Registration and Segmentation. (5) Pediatric Neuroradiology.

Unless otherwise indicated, scholarly articles published by Duke faculty members are made available here with a CC-BY-NC (Creative Commons Attribution Non-Commercial) license, as enabled by the Duke Open Access Policy. If you wish to use the materials in ways not already permitted under CC-BY-NC, please consult the copyright owner. Other materials are made available here through the author’s grant of a non-exclusive license to make their work openly accessible.