Simulating Disease Progression

Situation

A leading pharmaceutical company sought to reduce delays in its drug development cycle caused by prolonged cohort identification, protocol design, and feasibility analysis. The R&D team needed a more predictive, data-driven way to understand how diseases progress in real-world settings and how patients respond to various treatment strategies.

Challenge

Traditional methods for study design and feasibility testing were reactive, time-intensive, and disconnected from real-world patient progression. There was no scalable framework to simulate disease trajectories, anticipate treatment responses, or validate protocols before launching trials. This led to inefficiencies in trial setup, under-optimized inclusion criteria, and inflated control group sizes.

Approach

Mu Sigma partnered with the client to develop a digital simulation framework that modeled disease progression virtually, enabling hypothesis testing and protocol design before study execution.

• Data Integration: Combined clinical trial data and real-world data across structured and unstructured sources.
• Digital Twin Development: Created patient archetypes to simulate multiple disease trajectories based on historical treatment patterns and
  progression paths.
• Interactive Dashboard: Built a dynamic simulation tool with visual views of patient states, survival curves, and treatment outcomes under
  different protocol assumptions.
• Experimentation Platform: Enabled researchers to run virtual simulations on trial design options, optimizing key variables like
  inclusion/exclusion criteria and expected outcomes.

IMPACT

• Reduced protocol design time by 40%, enabling faster trial readiness.
• Allowed simulation of patient outcomes under various treatment pathways, improving confidence in study design.
• Enabled more precise inclusion criteria and optimized control arm sizing, reducing recruitment burden.
• Fostered cross-functional alignment between clinical, Health Economics and Outcomes Research (HEOR), and strategy teams by providing a common simulation platform.