In recent years, we have seen renewed and intensified efforts to make clinical development more patient centric and reduce the cost of the development process. The scarcity of patients with rare diseases, and the ethical concerns raised when gravely ill patients are enrolled in a placebo arm, have further highlighted the need to modernize approaches to drug development.
Before heading to ASCO, we published our latest article in Applied Clinical Trials. The article explores how a digital twin for Cytokine Release Syndrome (CRS) resulting from CAR-T therapy could be used in clinical development, and why digital twins will need to be considered in future approval submissions by regulatory bodies. CRS is a systemic inflammatory response that can result in some patients when CAR-T-infused cells release cytokines. Although uncommon to the point of almost being a rare disease, cytokine storm reactions can be fatal and can lead to widespread organ dysfunction; CRS-related mortality associated with CD19 CAR-T cell therapy is 5.4%.
Clinical data combined with advanced analytics and AI present a significant opportunity to accelerate clinical development by enabling researchers to predictively model patient safety and efficacy outcomes. In constructing a CAR-T CRS digital twin from a combination of real-world, clinical, cohort and patient data, Phesi found that a more effective treatment of CAR-T CRS should be able to suppress high grade CRS, and significantly reduce median grade CRS.
As CAR-T therapy becomes more widely used in oncology, sponsors will need to develop new and more effective treatments for CRS. Phesi’s digital twin approach can help streamline the clinical development process in this area, and the technique can be applied to many other rare or hard-to-study indications.
Our Phesi Trial Accelerator platform provides a global database of contextualized patient data from more than 480 000 curate trials and more than 60 million patients that sponsors can use to generate Digital Twins, define the target label, and design studies. Drop by Booth #19169 at ASCO to discover how patient-centric data can accelerate the development of new medicine, reduce patient and site burden, and minimize operational costs.