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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The Model can enhance trial design,<br />
CER, and product strategy<br />
• <strong>Clinical</strong> Trial Design<br />
– Appropriate powering (<strong>with</strong> knowledge <strong>of</strong> baseline/control arm event<br />
rates)<br />
– Observations on primary and secondary endpoint responses<br />
– Patient population segmenting<br />
– Examination <strong>of</strong> different permutations <strong>of</strong> I/E criteria, trial size, timelines,<br />
treatment effects<br />
• Comparative Effectiveness<br />
– Comparison on health outcomes<br />
– Comparison on costs<br />
– Examination <strong>of</strong> different permutations <strong>of</strong> patient subsets, practice<br />
guidelines, treatment compliance, clinical guideline adherence, costs<br />
• Product Strategy (Indication statement, Positioning, Pricing, etc.)<br />
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