Disease progression modeling (DPM) has the potential to support greater efficiency and better decision-making in clinical development, yet it remains underutilized compared with more established model-informed drug development approaches. To help advance its broader use, a new CTTI publication, published in the Journal of Clinical & Translational Science, provides evidence-based, cross-sector recommendations for applying DPM in medical product development.

In Empowering Clinical Development with Disease Progression Modeling: Recommendations from the Clinical Trials Transformation Initiative, the authors define DPM, describe its unique value in clinical development, and outline nine recommendations and a practical considerations framework to guide the use of DPM in medical product development.

The publication also presents strategic development questions and case examples demonstrating how DPM can inform decisions about indication, population, endpoint, and dose selection. By providing a shared vocabulary and structured questions for decision-makers and modelers, the article aims to lower barriers to DPM implementation, support the fit-for-purpose use of existing and new models, and enable more efficient, patient-focused, and sustainable clinical development.