JSM 2011 Online Program

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Abstract Details

Activity Number: 620
Type: Contributed
Date/Time: Thursday, August 4, 2011 : 8:30 AM to 10:20 AM
Sponsor: Section on Quality and Productivity
Abstract - #300833
Title: Experience of Redesign of a Bayesian Medical Device Trial
Author(s): Cathy Zeng*+
Companies: Medtronic inc.
Address: , , 55311,
Keywords: clinical trial design ; medical device ; Bayesian ; adaptive design
Abstract:

Bayesian clinical trial design is becoming more popular in the industry. The benefits of Bayesian clinical trial includes: adaptive sample size, balancing prior knowledge and current trial, modifiable probability distribution, etc. However, due to the intensive computation and relatively less usage in medical device clinical trials, some design may not be scientifically sound. Here we present our experience of a redesign of a Bayesian clinical trial in the medical device industry.


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