1. Figure 2 The imaging biomarker roadmap
Figure 2 | The imaging biomarker roadmap. A detailed schematic roadmap is depicted. The imaging biomarker (IB) roadmap differs from those described for biospecimen- derived biomarkers. For imaging, the technical and biological/clinical validation occur in parallel rather than sequentially. Of note, essential technical validation occurs late in the roadmap in many cases (such as full multicentre and multivendor reproducibility). Definitive clinical validation studies (IB measured against outcome) are deferred until technical validation is adequate for large trials. In the absence of definitive outcome studies, early biological validation can rely on a platform of very diverse graded evidence linking the IB to the underlying pathophysiology. Cost-effectiveness impacts on the roadmap at every stage, owing to the equipment and personnel costs of performing imaging studies. Technical validation and cost-effectiveness are important for IBs after crossing the translational gaps because hardware and software updates occur frequently. Therefore, technical performance and economic viability must be re-evaluated continuously. SOP, standard operating procedure. Image reproduced from
O’Connor, J. P. B. et al. (2016) Imaging biomarker roadmap for cancer studies
Nat. Rev. Clin. Oncol. doi: /nrclinonc