Imaging biomarker roadmap for cancer studies #MMPMID27725679
O?Connor JPB; Aboagye EO; Adams JE; Aerts HJWL; Barrington SF; Beer AJ; Boellaard R; Bohndiek SE; Brady M; Brown G; Buckley DL; Chenevert TL; Clarke LP; Collette S; Cook GJ; deSouza NM; Dickson JC; Dive C; Evelhoch JL; Faivre-Finn C; Gallagher FA; Gilbert FJ; Gillies RJ; Goh V; Griffiths JR; Groves AM; Halligan S; Harris AL; Hawkes DJ; Hoekstra OS; Huang EP; Hutton BF; Jackson EF; Jayson GC; Jones A; Koh DM; Lacombe D; Lambin P; Lassau N; Leach MO; Lee TY; Leen EL; Lewis JS; Liu Y; Lythgoe MF; Manoharan P; Maxwell RJ; Miles KA; Morgan B; Morris S; Ng T; Padhani AR; Parker GJM; Partridge M; Pathak AP; Peet AC; Punwani S; Reynolds AR; Robinson SP; Shankar LK; Sharma RA; Soloviev D; Stroobants S; Sullivan DC; Taylor SA; Tofts PS; Tozer GM; van Herk M; Walker-Samuel S; Wason J; Williams KJ; Workman P; Yankeelov TE; Brindle KM; McShane LM; Jackson A; Waterton JC
Nat Rev Clin Oncol 2017[Mar]; 14 (3): 169-86 PMID27725679show ga
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.
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Nat+Rev+Clin+Oncol 2017 ; 14 (3): 169-86
