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Reference: O'Connor, JPB, Aboagye, EO, Adams, JE et al., (2016). Imaging biomarker roadmap for cancer studies. Nature Reviews Clinical Oncology, 14 (3), 169–186.Citable link to this page:


Imaging biomarker roadmap for cancer studies

Abstract: Imaging biomarkers (IBs) are integral to the routine management of patients with cancer. IBs used daily in oncology include clinical TNM stage, objective response and left ventricular ejection fraction. Other CT, MRI, PET and ultrasonography biomarkers are used extensively in cancer research and drug development. New IBs need to be established either as useful tools for testing research hypotheses in clinical trials and research studies, or as clinical decision-making tools for use in healthcare, by crossing 'translational gaps' through validation and qualification. Important differences exist between IBs and biospecimen-derived biomarkers and, therefore, the development of IBs requires a tailored 'roadmap'. Recognizing this need, Cancer Research UK (CRUK) and the European Organisation for Research and Treatment of Cancer (EORTC) assembled experts to review, debate and summarize the challenges of IB validation and qualification. This consensus group has produced 14 key recommendations for accelerating the clinical translation of IBs, which highlight the role of parallel (rather than sequential) tracks of technical (assay) validation, biological/clinical validation and assessment of cost-effectiveness; the need for IB standardization and accreditation systems; the need to continually revisit IB precision; an alternative framework for biological/clinical validation of IBs; and the essential requirements for multicentre studies to qualify IBs for clinical use.

Publication status:PublishedPeer Review status:Peer reviewedVersion:Publisher's version Funder: Cancer Research UK   Funder: Engineering and Physical Sciences Research Council   Funder: Innovative Medicines Initiative Joint Undertaking   Funder: European Union   Notes:This work is licensed under a Creative Commons Attribution 4.0 International License. The images or other third party material in this article are included in the article's Creative Commons license, unless indicated otherwise in the credit line; if the material is not included under the Creative Commons license, users will need to obtain permission from the license holder to reproduce the material. To view a copy of this license, visit

Bibliographic Details

Publisher: Nature Publishing Group

Publisher Website:

Journal: Nature Reviews Clinical Oncologysee more from them

Publication Website:

Volume: 14

Issue: 3

Extent: 169–186

Issue Date: 2016


Urn: uuid:710f322f-6638-4f10-8292-6230099f70fc

Eissn: 1759-4782

Issn: 1759-4774

Source identifier: 620003

Doi: Item Description

Type: Journal article;

Version: Publisher's version Tiny URL: pubs:620003


Autor: O'Connor, JPB - - - Aboagye, EO - - - Adams, JE - - - Aerts, HJWL - - - Barrington, SF - - - Beer, AJ - - - Boellaard, R - -



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