title: 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.
authors.affiliation: University of Washington, Seattle, WA, USA kesslerl@uw.edu.
authors.forename: Larry G
authors.initials: LG
authors.lastname: Kessler
authors.affiliation: Duke University, Durham, NC, USA.
authors.forename: Huiman X
authors.initials: HX
authors.lastname: Barnhart
authors.affiliation: Elucid Bioimaging Inc, Wenham, MA, USA.
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Buckler
authors.affiliation: Duke University, Durham, NC, USA.
authors.forename: Kingshuk Roy
authors.initials: KR
authors.lastname: Choudhury
authors.affiliation: Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Marina V
authors.initials: MV
authors.lastname: Kondratovich
authors.affiliation: Biostatistics Consulting, LLC, Kensington, MD, USA.
authors.forename: Alicia
authors.initials: A
authors.lastname: Toledano
authors.affiliation: Harvard-Massachusetts General Hospital, Boston, MA, USA.
authors.forename: Alexander R
authors.initials: AR
authors.lastname: Guimaraes
authors.affiliation: Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Ross
authors.initials: R
authors.lastname: Filice
authors.affiliation: Brown University, Providence, RI, USA.
authors.forename: Zheng
authors.initials: Z
authors.lastname: Zhang
authors.affiliation: Duke University, Durham, NC, USA.
authors.forename: Daniel C
authors.initials: DC
authors.lastname: Sullivan
mesh_terms: D015415:Biomarkers; D003952:Diagnostic Imaging; D006801:Humans; D013223:Statistics as Topic; D009626:Terminology as Topic
chemical_list: D015415:Biomarkers
keywords: Quantitative; bias; definitions; precision; terminology