The emerging science of quantitative imaging biomarkers terminology and definitions for scientific studies and regulatory submissions.

Abstract

The development and implementation of quantitative imaging biomarkers has been hampered by the inconsistent and often incorrect use of terminology related to these markers. Sponsored by the Radiological Society of North America, an interdisciplinary group of radiologists, statisticians, physicists, and other researchers worked to develop a comprehensive terminology to serve as a foundation for quantitative imaging biomarker claims. Where possible, this working group adapted existing definitions derived from national or international standards bodies rather than invent new definitions for these terms. This terminology also serves as a foundation for the design of studies that evaluate the technical performance of quantitative imaging biomarkers and for studies of algorithms that generate the quantitative imaging biomarkers from clinical scans. This paper provides examples of research studies and quantitative imaging biomarker claims that use terminology consistent with these definitions as well as examples of the rampant confusion in this emerging field. We provide recommendations for appropriate use of quantitative imaging biomarker terminological concepts. It is hoped that this document will assist researchers and regulatory reviewers who examine quantitative imaging biomarkers and will also inform regulatory guidance. More consistent and correct use of terminology could advance regulatory science, improve clinical research, and provide better care for patients who undergo imaging studies.

Department

Description

Provenance

Citation

Published Version (Please cite this version)

10.1177/0962280214537333

Publication Info

Kessler, Larry G, Huiman X Barnhart, Andrew J Buckler, Kingshuk Roy Choudhury, Marina V Kondratovich, Alicia Toledano, Alexander R Guimaraes, Ross Filice, et al. (2015). The emerging science of quantitative imaging biomarkers terminology and definitions for scientific studies and regulatory submissions. Statistical methods in medical research, 24(1). pp. 9–26. 10.1177/0962280214537333 Retrieved from https://hdl.handle.net/10161/18037.

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Scholars@Duke

Barnhart

Huiman Xie Barnhart

Professor of Biostatistics & Bioinformatics

My research interests include both statistical methodology and disease-specific clinical research biostatistics. My statistical research areas include methods for outcomes, endpoints, estimands, assessing reliability/agreement between methods or raters, evaluating performance of new medical diagnostic tests, and methods for design of clinical trials. My collaborative research include the following clinical areas: liver injury, cardiovascular imaging, radiology imaging, cardiovascular disease, renal disease, reproductive medicine, Parkinson disease, and aging.

Sullivan

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.


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