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Activity Number: 245
Type: Contributed
Date/Time: Monday, August 4, 2014 : 2:00 PM to 2:45 PM
Sponsor: Biopharmaceutical Section
Abstract #313993
Title: A Bayesian Adaptive Design with Time-to-Event Data for Claiming Noninferiority for Therapeutic Cardiovascular Medical Device
Author(s): Baohui Zhang*+ and Hui Wang
Companies: Johnson & Johnson and Consultant
Keywords: Bayesian Adaptive Design ; Time-to-Event ; Non-inferiority Trial ; Clinical Trial ; Medical Device
Abstract:

It is often of interest to a medical device company to compare a novel device to a currently marketed product and demonstrate the non-inferiority of the novel device with the marketed one. Historical knowledge, such as survival curves and probabilities, often exists for such trials, and Bayesian approaches provide a natural framework to incorporate such prior information.

We present a non-inferiority trial of a cardiovascular medical device within a Bayesian adaptive design framework for time-to-event data. Based on historical data from previous trials, we model the time-to-event with a three-piece exponential distribution. Time intervals and hazard ratios are estimated with a MCMC algorithm. The operating characteristics of the Bayesian adaptive design are examined with simulations and compared with non-adaptive and group sequential methods to demonstrate its effectiveness in sample size reduction.


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