Webinar - 20 Mar 4 PM EST - Simulation Modeling for Optimizing Design of Clinical Trials
On March 20, Badri Rengarajan, medical director at Archimedes, will host a webinar providing an overview of simulation modeling and how it can be used to improve clinical development efforts.
Dr. Rengarajan will highlight how simulation modeling helped Orexigen formulate the study design for its pre-approval CV outcomes trial. This study protocol was cleared by the FDA in February, overcoming a complete response letter issued in early 2011.
Clinical trial and registry programs can greatly benefit from simulation modeling as they frequently fail to achieve their intended clinical and commercial impact. Failure can be attributed to several reasons, including:
- Poor prediction of efficacy and safety profile
- Inadequate powering due to uncertainty in baseline/control arm event rate
- Unknown performance in a real-world setting (with comorbidities, less-than-perfect medication compliance, and uncertain adherence to clinical guidelines)
- Lack of head-to-head or comparative effectiveness data
Simulation provides the ability to test trial and registry designs before implementing them. It can estimate eligible population size and baseline event rates, and anticipate trial performance under different variations in inclusion/exclusion criteria, protocols, and patient/physician behaviors.
Simulation provides the ability to project years forward in time and to test multiple variations in design before a trial protocol is finalized, thereby reducing risk, time, and cost.
