JSM 2005 - Toronto

Abstract #303668

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Legend: = Applied Session, = Theme Session, = Presenter
Activity Number: 388
Type: Topic Contributed
Date/Time: Wednesday, August 10, 2005 : 10:30 AM to 12:20 PM
Sponsor: Section on Bayesian Statistical Science
Abstract - #303668
Title: Bayesian Experimental Design of Sequential and Nonsequential Medical Device Trials
Author(s): George G. Woodworth*+ and David Breiter and Mah Jeng
Companies: The University of Iowa and Guidant Corporation and Guidant Corporation
Address: Department of Statistics and Actuarial Science, Iowa City, IA, 52242, United States
Keywords: Bayesian ; non-inferiority ; sequential ; design
Abstract:

The purpose of a noninferiority trial for a medical device, or other clinical intervention, is to demonstrate that the device is not clinically inferior to currently approved devices of the same type. A coherent Bayesian approach to the design of a sequential noninferiority trial requires the choice of sample size and interim and terminal decisions minimize expected loss (or maximize expected utility). This paper suggests a loss function that justifies basing design decisions on Bayesian Type-I and Type-II errors. The approach is illustrated for a normal endpoint with staggered patient entry with and without interim looks. Binary endpoint cases and time to failure (survival) models also are examined in the case of staggered entry and interim looks.

It is sometimes not recognized that, in Bayesian theory, although the presence or absence of interim looks does not alter the posterior distribution based on current data, planned interim looks do present more opportunities for error and therefore alter the preposterior expected loss and influence the choice of sample size and interim decisions.

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Revised March 2005