New CTTI Project Aims to Promote the Use of Disease Progression Modeling to Advance Trial Design and Decision Making
Modeling and simulations are powerful tools that can be leveraged to inform clinical trial design, support regulatory decision making, and accelerate the process of bringing treatments to patients. Despite the benefits of these methods, their use is still not widely accepted among sponsors, investigators, and regulators. Recently, there has been growing interest across the clinical trials ecosystem in advancing the use of disease progression modeling to improve clinical trial quality and efficiency and inform regulatory decision making. Disease progression modeling leverages data from a variety of sources, improving trial diversity and combining many different models to help inform decision making.
To promote these methods, CTTI has started a new project engaging a variety of stakeholders and experts in the development of recommendations and resources for the application of disease progression modeling in clinical trials. Through this project, CTTI will generate case studies detailing successful applications of disease progression modeling, a framework for the execution of disease progression modeling in clinical trials, a set of recommendations for the implementation of disease progression modeling in clinical trials, and a review paper detailing relevant disease progression modeling applications. This project aims to improve trial and clinical development efficiency by increasing the recognition, value, and consistent use of disease progression modeling. CTTI’s work in this area will also help to advance the broader application of modeling and simulation for trial design and regulatory decision making.
To generate recommendations and resources supporting the application of disease progression modeling in clinical trials, CTTI will utilize a variety of iterative evidence generating strategies—including a scoping review assessing the landscape of disease progression modeling applications and an expert meeting discussing the barriers to disease progression modeling application and avenues for advancement.
Through this work, CTTI will create recommendations and resources for designing clinical trials with a quality approach that maximally leverages available data—in alignment with CTTI’s Transforming Trials 2030 vision.