Simulation of Clinical Trials with Mathematical Models ... - CBI

Simulation methods have their own challenges,
and differ in their capabilities
Potential Challenges
• Limited to current knowledge of drug action, efficacy/effectiveness,
safety, dosing
• May not capture off-target toxicities
• Not a substitute for a real trial
Differences Among Methods
• Level of accuracy in capturing physiological and pathophysiological
relationships
• Level of integration across different organs and disease processes
• Ability to capture clinical care processes
• Ability to capture healthcare system costs
• Ability to capture downstream/ripple effects on outcomes and costs
6