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

Larry G. Kessler, Huiman X. Barnhart, Andrew J. Buckler, Kingshuk Roy Choudhury, Marina V. Kondratovich, Alicia Toledano, Alexander Guimaraes, Ross Filice, Zheng Zhang, Daniel C. Sullivan

Research output: Contribution to journalArticle

108 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)9-26
Number of pages18
JournalStatistical Methods in Medical Research
Volume24
Issue number1
DOIs
StatePublished - Feb 27 2015
Externally publishedYes

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Biomarkers
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Keywords

  • bias
  • definitions
  • precision
  • Quantitative
  • terminology

ASJC Scopus subject areas

  • Epidemiology
  • Health Information Management
  • Statistics and Probability

Cite this

Kessler, L. G., Barnhart, H. X., Buckler, A. J., Choudhury, K. R., Kondratovich, M. V., Toledano, A., ... Sullivan, D. C. (2015). The emerging science of quantitative imaging biomarkers terminology and definitions for scientific studies and regulatory submissions. Statistical Methods in Medical Research, 24(1), 9-26. https://doi.org/10.1177/0962280214537333

The emerging science of quantitative imaging biomarkers terminology and definitions for scientific studies and regulatory submissions. / Kessler, Larry G.; Barnhart, Huiman X.; Buckler, Andrew J.; Choudhury, Kingshuk Roy; Kondratovich, Marina V.; Toledano, Alicia; Guimaraes, Alexander; Filice, Ross; Zhang, Zheng; Sullivan, Daniel C.

In: Statistical Methods in Medical Research, Vol. 24, No. 1, 27.02.2015, p. 9-26.

Research output: Contribution to journalArticle

Kessler, LG, Barnhart, HX, Buckler, AJ, Choudhury, KR, Kondratovich, MV, Toledano, A, Guimaraes, A, Filice, R, Zhang, Z & Sullivan, DC 2015, 'The emerging science of quantitative imaging biomarkers terminology and definitions for scientific studies and regulatory submissions', Statistical Methods in Medical Research, vol. 24, no. 1, pp. 9-26. https://doi.org/10.1177/0962280214537333
Kessler, Larry G. ; Barnhart, Huiman X. ; Buckler, Andrew J. ; Choudhury, Kingshuk Roy ; Kondratovich, Marina V. ; Toledano, Alicia ; Guimaraes, Alexander ; Filice, Ross ; Zhang, Zheng ; Sullivan, Daniel C. / The emerging science of quantitative imaging biomarkers terminology and definitions for scientific studies and regulatory submissions. In: Statistical Methods in Medical Research. 2015 ; Vol. 24, No. 1. pp. 9-26.
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