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Activity Number: 615
Type: Contributed
Date/Time: Wednesday, August 12, 2015 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #317409 View Presentation
Title: Basket Trial Using Bayesian Hierarchical Models
Author(s): Zijiang Yang*
Companies:
Keywords: Basket trial ; Bayesian hierarchical ; clinical trial ; subgroup analysis
Abstract:

Basket trials are often viewed as parallel phase II trials within the same entity. In a clinical trial evaluating a new class of antibiotics, it is usually believed that the investigational drug would be effective against a certain type of bacteria regardless of the infected site (lung, urine tract, blood stream, etc.). This would allow the sponsor to evaluate the efficacy across different diseases in a single trial. Bayesian analytic methods using hierarchical models could allow information to be flexibly "pooled" across disease subgroups given the consistency in the observed treatment effect. The "borrowed" strength yields greater precision in the estimation of the treatment effect and improves trial efficiency. Simulation work has been done to assess the performance of such a design over traditional analysis in which data from each subgroup is analyzed separately. It also reveals the scenarios when the Bayesian methodology would cause unwanted results and when we should not use such methods.


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