Simulation of Clinical Trials with Mathematical Models ... - CBI
Simulation of Clinical Trials with Mathematical Models ... - CBI
Simulation of Clinical Trials with Mathematical Models ... - CBI
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There are several ways to try to predict results<br />
<strong>of</strong> trials, each has limitations<br />
5<br />
Mechanism<br />
Comparison <strong>of</strong> trials for different<br />
treatments<br />
(also tests, devices, procedures)<br />
Registry data<br />
Questionnaires for physicians,<br />
patients<br />
Potential Limitations<br />
• “Apples vs. Oranges” comparisons<br />
̶ Different patient populations<br />
̶ Different interventions<br />
̶ Different endpoints/outcomes<br />
• Confounding factors<br />
• Missing/incomplete data<br />
• Calibration <strong>of</strong> responses<br />
• Inability to verify<br />
PK/PD modeling<br />
Pilot trial<br />
• May not be predictive <strong>of</strong> clinical<br />
outcomes – too far upstream<br />
• Insufficient powering<br />
• Requires time for protocol development,<br />
enrollment, and analysis
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