Imaging biomarker roadmap for cancer studies Journal Article


Authors: O'Connor, J. P. B.; Aboagye, E. O.; Adams, J. E.; Aerts, H. J. W. L.; Barrington, S. F.; Beer, A. J.; Boellaard, R.; Bohndiek, S. E.; Brady, M.; Brown, G.; Buckley, D. L.; Chenevert, T. L.; Clarke, L. P.; Collette, S.; Cook, G. J.; Desouza, N. M.; Dickson, J. C.; Dive, C.; Evelhoch, J. L.; Faivre-Finn, C.; Gallagher, F. A.; Gilbert, F. J.; Gillies, R. J.; Goh, V.; Griffiths, J. R.; Groves, A. M.; Halligan, S.; Harris, A. L.; Hawkes, D. J.; Hoekstra, O. S.; Huang, E. P.; Hutton, B. F.; Jackson, E. F.; Jayson, G. C.; Jones, A.; Koh, D. M.; Lacombe, D.; Lambin, P.; Lassau, N.; Leach, M. O.; Lee, T. Y.; Leen, E. L.; Lewis, J. S.; Liu, Y.; Lythgoe, M. F.; Manoharan, P.; Maxwell, R. J.; Miles, K. A.; Morgan, B.; Morris, S.; Ng, T.; Padhani, A. R.; Parker, G. J. M.; Partridge, M.; Pathak, A. P.; Peet, A. C.; Punwani, S.; Reynolds, A. R.; Robinson, S. P.; Shankar, L. K.; Sharma, R. A.; Soloviev, D.; Stroobants, S.; Sullivan, D. C.; Taylor, S. A.; Tofts, P. S.; Tozer, G. M.; van Herk, M.; Walker-Samuel, S.; Wason, J.; Williams, K. J.; Workman, P.; Yankeelov, T. E.; Brindle, K. M.; McShane, L. M.; Jackson, A.; Waterton, J. C.
Article Title: 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.
Keywords: drug development; end-points; contrast-enhanced mri; breast-cancer; clinical-trials; positron-emission-tomography; high familial risk; cell lung-cancer; advanced solid tumors; surrogate; group developmental pathway
Journal Title: Nature Reviews Clinical Oncology
Volume: 14
Issue: 3
ISSN: 1759-4774
Publisher: Nature Publishing Group  
Date Published: 2017-03-01
Start Page: 169
End Page: 186
Language: English
ACCESSION: WOS:000396836100006
DOI: 10.1038/nrclinonc.2016.162
PROVIDER: wos
PMCID: PMC5378302
PUBMED: 27725679
Notes: Article -- Source: Wos
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  1. Jason S Lewis
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