Incorporation of stochastic engineering models as prior information in Bayesian medical device trials and post-market surveillance
*Tarek Haddad , Medtronic Adam Himes, Medtronic Inc Telba Irony, FDA Rajesh Nair, FDA/CDRH Laura Thompson, FDA Keywords: virtual patients, simulation, bayesian clinical trial, Modern implantable medical devices have brought improved quality of life to many patients. Evaluation via clinical trial is often a necessary step in the process of bringing a new product to market. In recent years, device manufacturers are increasingly using stochastic engineering models during the product development process. 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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Key Dates
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June 3, 2014 - September 7, 2015
Online Registration -
June 3, 2015 - August 15, 2015
Housing -
July 31 - August 17, 2015
Invited Abstract Editing -
August 10, 2015
Short Course materials due from Instructors -
August 26, 2015
Advanced Registration Deadline -
September 7, 2015
Cancellation Deadline -
September 16 - 18, 2015
Marriott Wardman Park, Washington, DC