Integrating radiomics into clinical trial design.

In radiomics, quantitative features that describe phenotypic tumor characteristics are derived from radiographic images. Because radiomics generates information from routine medical images, it is a powerful way to non-invasively examine the spatial and temporal heterogeneity of disease, and thus has potential to significantly impact clinical trial design, execution, and ultimately patient care. The aim of this review article is to discuss how radiomics may address some of the current challenges in clinical randomized control trials, and the difficulties of integrating robust and repeatable radiomics analysis into trial design. Each step of the radiomics process, including image acquisition and reconstruction, image segmentation, feature extraction, and computational analysis, requires extensive standardization in order to be successfully incorporated into clinical trials and inform clinical decision making. By addressing these challenges, the potential of radiomics may be realized.