JSM 2005 - Toronto

Abstract #303635

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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 - #303635
Title: A Bayesian Adaptive Sample Design in Comparing Hazard Rates of Two Therapies
Author(s): Feng Tang*+ and Lou Sherfesee and Andrew Mugglin
Companies: Medtronic, Inc. and Medtronic, Inc. and Medtronic, Inc.
Address: 1015 Gramsie Road, Saint Paul, MN, 55126,
Keywords: Adaptive Bayesian Design ; Piecewise exponential model ; Posterior Predictive Probability ; Interim Analyses ; Frequentist Operating Characteristics
Abstract:

In this talk, we present an adaptive Bayesian design in a clinical trial in which the goal is to determine the superiority of one therapy over another as measured by the hazard rates of occurrence of a composite endpoint. A proportional hazards piecewise exponential model is used. The initial sample size was determined using a logrank test based on estimated hazard rates of historical data. However, the historical data may be unreliable, making the initial sample size insufficient. Therefore, the adaptive design will consist of an initial sample size, but will allow it to be increased incrementally if necessary. Two formal interim analyses are planned, at which a set of Bayesian criteria in the form of both posterior probability and posterior predictive probability will be evaluated in order to decide whether to stop the trial early for success or safety, to stop enrollment for futility, or to increase the sample size. In addition, a variable number of sample size reestimations may occur. Prior to the first enrollment, frequentist operating characteristics were evaluated so the overall type-I error and power were acceptable.

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Revised March 2005