The Science of Quantitative Imaging Biomarkers

February 5, 2016

The development and implementation of quantitative imaging biomarkers (QIB) has been hindered by inconsistent and frequently incorrect use of terminology used to describe these biomarkers.   Kessler et al. (2014) recently published an article ( , produced with sponsorship from the Radiological Society of North America (RSNA), to address the terminology and definitions of quantitative imaging biomarkers to be used in scientific studies and regulatory submissions. The Quantitative Imaging Biomarker Alliance(QIBA), organized by RSNA, emphasized “building measuring devices rather than imaging devices”, that is extracting data from images to provide numerical data to the clinicians and regulatory agencies. Terms defined and reviewed in the paper were drawn from national or international standards bodies instead of defining new terms. Quantitative imaging biomarkers are clearly defined, and their “context of use, acquisition parameters, measurement methodology and quantification of their variability and error” are described. This paper provides a firm foundation for use of QIB by clearly defining the attributes of the imaging biomarker to be measured, and by providing a framework for determining its variability and error.

Elucid Bioimaging Inc. is a specialty CRO and leader in quantitative image analysis services to characterize, optimize, and validate imaging biomarkers for drug development to improve the effectiveness and reduce the cost of clinical trials of novel therapies and develop improved tools for medical decisions and patient management.