O'Connor, James PBAboagye, Eric OAdams, Judith EAerts, Hugo JWLBarrington, Sally FBeer, Ambros JBoellaard, RonaldBohndiek, Sarah EBrady, MichaelBrown, GinaBuckley, David LChenevert, Thomas LClarke, Laurence PCollette, SandraCook, Gary JdeSouza, Nandita MDickson, John CDive, CarolineEvelhoch, Jeffrey LFaivre-Finn, CorinneGallagher, Ferdia AGilbert, Fiona JGillies, Robert JGoh, VickyGriffiths, John RGroves, Ashley MHalligan, SteveHarris, Adrian LHawkes, David JHoekstra, Otto SHuang, Erich PHutton, Brian FJackson, Edward FJayson, Gordon CJones, AndrewKoh, Dow-MuLacombe, DenisLambin, PhilippeLassau, NathalieLeach, Martin OLee, Ting-YimLeen, Edward LLewis, Jason SLiu, YanLythgoe, Mark FManoharan, PrakashMaxwell, Ross JMiles, Kenneth AMorgan, BrunoMorris, SteveNg, TonyPadhani, Anwar RParker, Geoff JMPartridge, MikePathak, Arvind PPeet, Andrew CPunwani, ShonitReynolds, Andrew RRobinson, Simon PShankar, Lalitha KSharma, Ricky ASoloviev, DmitryStroobants, SigridSullivan, Daniel CTaylor, Stuart ATofts, Paul STozer, Gillian Mvan Herk, MarcelWalker-Samuel, SimonWason, JamesWilliams, Kaye JWorkman, PaulYankeelov, Thomas EBrindle, Kevin MMcShane, Lisa MJackson, AlanWaterton, John C2019-02-012019-02-012017-031759-47741759-4782https://hdl.handle.net/10161/18011Imaging 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.HumansNeoplasmsOrganotechnetium CompoundsFolic AcidFluorodeoxyglucose F18RadiopharmaceuticalsPositron-Emission TomographyPrognosisReproducibility of ResultsSelection BiasResearch DesignCost-Benefit AnalysisBiomarkers, TumorClinical Decision-MakingJournal article2019-02-01