New consensus guidelines provide a "road map" for the appropriate implementation of imaging biomarkers in clinical practice.
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Imaging biomarkers are used frequently in oncology to diagnose cancers, target treatments, guide the development of investigational drugs, and identify potentially effective drugs early in the developmental stages so as to accelerate market approval.
Despite the widespread benefits of using imaging biomarkers, only a limited number of biomarkers actually guide clinical decisions. Some cancer biomarkers do not get adopted because they do not measure a biological feature, enable disease diagnosis, or outcome prediction and consequently are devalidated.
With new guidelines published in Nature Reviews Clinical Oncology, James P.B. O’Connor, PhD, Cancer Research UK Clinician Scientist Fellow and Group Leader, University of Manchester (UK), and colleagues provide a suggested road map to follow when translating imaging biomarkers to clinical practice. The road map includes two “transitional gaps” the imaging biomarkers must cross in order to be deemed useful “medical research tools” and then “clinical decision-making tools.” If an imaging biomarkers is reliable in testing medical hypotheses in both animals and humans, then it crosses the first transitional gap to becoming a medical research tool. If the imaging biomarker is a reliable measure used to test hypotheses in clinical cancer research, then it crosses the second transitional gap to becoming a clinical decision-making tool. The imaging biomarker can then be used routinely in the management of patients with cancer.
The authors suggest that two validation methods be used to test imaging biomarkers. The first, technical validation, determines whether the biomarker is measurable precisely and accurately and whether it is widely accessible. The second, biological and clinical validation, determines whether the biomarker can be used to measure a relevant aspect of biology or predict clinical outcome. Strategies to mitigate and quantify the potential risks and costs associated with the biomarker in making research or clinical decisions must also be considered.
Authors of the guidelines believe their recommendations will mark a change in the development and use of imaging biomarkers in cancer research, patient management, and clinical decision-making by requiring imaging biomarkers to “undergo rigorous scrutiny through validation and qualification” before their use.
