title: Quantitative imaging biomarkers: a review of statistical methods for technical performance assessment.
abstract: Technological developments and greater rigor in the quantitative measurement of biological features in medical images have given rise to an increased interest in using quantitative imaging biomarkers to measure changes in these features. Critical to the performance of a quantitative imaging biomarker in preclinical or clinical settings are three primary metrology areas of interest: measurement linearity and bias, repeatability, and the ability to consistently reproduce equivalent results when conditions change, as would be expected in any clinical trial. Unfortunately, performance studies to date differ greatly in designs, analysis method, and metrics used to assess a quantitative imaging biomarker for clinical use. It is therefore difficult or not possible to integrate results from different studies or to use reported results to design studies. The Radiological Society of North America and the Quantitative Imaging Biomarker Alliance with technical, radiological, and statistical experts developed a set of technical performance analysis methods, metrics, and study designs that provide terminology, metrics, and methods consistent with widely accepted metrological standards. This document provides a consistent framework for the conduct and evaluation of quantitative imaging biomarker performance studies so that results from multiple studies can be compared, contrasted, or combined.
authors.affiliation: ICON Medical Imaging, Warrington, USA David.Raunig@iconplc.com.
authors.forename: David L
authors.initials: DL
authors.lastname: Raunig
authors.affiliation: National Cancer Institute, Bethesda, USA.
authors.forename: Lisa M
authors.initials: LM
authors.lastname: McShane
authors.affiliation: Food and Drug Administration/CDRH, Silver Spring, USA.
authors.forename: Gene
authors.initials: G
authors.lastname: Pennello
authors.affiliation: Brown University, Providence, USA.
authors.forename: Constantine
authors.initials: C
authors.lastname: Gatsonis
authors.affiliation: University of Michigan Health System, Ann Arbor, USA.
authors.forename: Paul L
authors.initials: PL
authors.lastname: Carson
authors.affiliation: Duke University BIAC, Durham, USA.
authors.forename: James T
authors.initials: JT
authors.lastname: Voyvodic
authors.affiliation: Johns Hopkins Medical Institute, Baltimore, MD, USA.
authors.forename: Richard L
authors.initials: RL
authors.lastname: Wahl
authors.affiliation: University of Pittsburgh, Pittsburg, USA.
authors.forename: Brenda F
authors.initials: BF
authors.lastname: Kurland
authors.affiliation: Eli Lilly and Co, Indianapolis, USA.
authors.forename: Adam J
authors.initials: AJ
authors.lastname: Schwarz
authors.affiliation: Memorial Sloan Kettering Cancer Center, New York, USA.
authors.forename: Mithat
authors.initials: M
authors.lastname: Gönen
authors.affiliation: Hoffman-La Roche Ltd., Basel, CH.
authors.forename: Gudrun
authors.initials: G
authors.lastname: Zahlmann
authors.affiliation: Food and Drug Administration/CDRH, Silver Spring, USA.
authors.forename: Marina V
authors.initials: MV
authors.lastname: Kondratovich
authors.affiliation: Toshiba Medical Research Institute, Vernon Hills, USA.
authors.forename: Kevin
authors.initials: K
authors.lastname: O'Donnell
authors.affiliation: Food and Drug Administration/CDRH, Silver Spring, USA.
authors.forename: Nicholas
authors.initials: N
authors.lastname: Petrick
authors.affiliation: Takaeda, Deerfield, USA.
authors.forename: Patricia E
authors.initials: PE
authors.lastname: Cole
authors.affiliation: Food and Drug Administration/CDRH, Silver Spring, USA.
authors.forename: Brian
authors.initials: B
authors.lastname: Garra
authors.affiliation: Duke University School of Medicine, Durham, USA.
authors.forename: Daniel C
authors.initials: DC
authors.lastname: Sullivan
mesh_terms: D015982:Bias; D015415:Biomarkers; D002986:Clinical Trials as Topic; D003952:Diagnostic Imaging; D006801:Humans; D015203:Reproducibility of Results; D012107:Research Design; D013223:Statistics as Topic; D009626:Terminology as Topic
chemical_list: D015415:Biomarkers
keywords: agreement; bias; imaging biomarkers; linearity; precision; quantitative imaging; reliability; repeatability; reproducibility