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Activity Number: 178
Type: Contributed
Date/Time: Monday, August 5, 2013 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #307881
Title: Bayesian PPOS Design for Pilot Drug Development
Author(s): Zhongwen Tang*+ and Jyotirmoy Dey
Companies: Novartis Oncology and Novartis Oncology
Keywords: Bayesian ; clinical trial design ; predictive probability of success
Abstract:

Traditional pilot trial design is based on type I error and power, which is not very appropriate due to the exploratory nature of pilot trials. We proposed a pilot trial design based on predictive probability of success (PPOS) in future confirmatory trial. Our method control controls false positive (negative) rate in a Bayesian setting. But the analysis of data is still based on a Frequentist method, which reflects the reality that most of the confirmatory trials are analyzed this way. Our approach can be applied to different end points. We have also developed a user-friendly software to support the computation of the proposed method.


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