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Activity Number:
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382
- Improving the Efficiency of Medical Device Clinical Trials by Combining Simulations and Experiments
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Type:
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Invited
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Date/Time:
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Tuesday, August 1, 2017 : 2:00 PM to 3:50 PM
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Sponsor:
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Section on Medical Devices and Diagnostics
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Abstract #322277
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View Presentation
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Title:
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Incorporation of Stochastic Engineering Models as Prior Information in Bayesian Medical Device Trials
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Author(s):
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Valentin Parvu*
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Companies:
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BDX Corporate/Shared services, BD
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Keywords:
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medical device ;
simulations ;
Bayesian ;
adaptive ;
virtual patients ;
engineering models
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Abstract:
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Stochastic engineering models are being increasingly used during the product development process for medical devices. These models have the capability to simulate virtual patient outcomes. Incorporation of these models as prior knowledge in a Bayesian clinical trial design can provide benefits of decreased sample size and trial length while still controlling type I and type II error rates. This paper presents a straightforward method for augmenting a clinical trial using virtual patient data, where the number of virtual patients is based on the similarity between modeled and observed data. The use of this method is illustrated by a case study based on a model for cardiac lead fracture.
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Authors who are presenting talks have a * after their name.
