CTTI today released new recommendations to support the effective use of disease progression modeling (DPM) in medical product development. The goal is to enable smarter, more efficient, and more evidence-based decisions by identifying when DPM should be considered and what is needed to implement it successfully. 

A disease progression model is a mathematical model that quantitatively describes the time course or trajectory of a disease. When used appropriately, DPM can integrate diverse sources of data—including translational, clinical, and real-world data—to improve trial design, reduce uncertainty, and tailor development strategies toward more personalized, targeted approaches. It can also help address knowledge gaps, support regulatory engagement, and strengthen the totality of evidence on a product’s benefit-risk profile. 

“DPM has tremendous potential to enhance decision making across the development lifecycle, particularly when having knowledge of the disease course is critical,” said Lindsay Kehoe, CTTI Senior Project Manager. “These recommendations are designed to help cross-functional leaders ask the right questions, appreciate the unique value of DPM, and apply it in ways that lead to better outcomes for patients.” 

Many decision makers in medical product development face uncertainty around when and how to apply DPM, and how to weigh its benefits alongside other modeling approaches. CTTI’s recommendations offer practical guidance to address these challenges and support more strategic, efficient decision making across clinical, regulatory, and translational functions. 

The recommendations were developed by experts from across the clinical trials ecosystem and further refined by a multi-stakeholder recommendations advisory group. 

More information on the Disease Progression Modeling project is available on CTTI’s website.