Imaging biomarkers have emerged as increasingly important endpoints in cancer clinical trials. Incorporating tumor metric reads as part of routine clinical reads by on-site radiologists for cancer clinical trials has several challenges which can be addressed by tumor metrics imaging core lab. Despite the operational and financial challenges inherent in establishing and maintaining tumor metrics imaging core labs, including workflow complexities, infrastructure demands, and data security considerations, these facilities confer significant advantages including accelerated trial timelines, improved regulatory compliance, and the creation of interdisciplinary research environments. Moreover, the integration of artificial intelligence within tumor metrics imaging core labs offers enhanced image analysis, predictive modeling, and improved trial efficiency. This article provides a comprehensive review of the role of tumor metrics imaging core labs in clinical trials and provides an overview of the key components involved in setting up a core lab. We will also briefly present the challenges in the successful operation of a tumor metrics imaging core lab and delve into the potential solutions, including the integration of AI tools for clinical trials.
Gurudu et al. (Tue,) studied this question.