Radiomics in clinical trials: perspectives on standardization

The term biomarker is used to describe a biological measure of the disease behavior. The existing imaging biomarkers are associated with the known tissue biological characteristics and follow a well-established roadmap to be implemented in routine clinical practice. Recently, a new quantitative imaging analysis approach named radiomics has emerged. It refers to the extraction of a large number of advanced imaging features with high-throughput computing. Extensive research has demonstrated its value in predicting disease behavior, progression, and response to therapeutic options. However, there are numerous challenges to establishing it as a clinically viable solution, including lack of reproducibility and transparency. The data-driven nature also does not offer insights into the underpinning biology of the observed relationships. As such, additional effort is needed to establish it as a qualified biomarker to inform clinical decisions. Here we review the technical difficulties encountered in the clinical applications of radiomics and current effort in addressing some of these challenges in clinical trial designs. By addressing these challenges, the true potential of radiomics can be unleashed.