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Activity Number:
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51
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Type:
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Topic Contributed
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Date/Time:
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Sunday, July 29, 2007 : 4:00 PM to 5:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #309943 |
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Title:
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A Bayesian Approach to Evaluation of Bridging Evidence
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Author(s):
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Hsiao-Hui Tsou*+ and Chin-Fu Hsiao and Yu-Yi Hsu and Jen-pei Liu
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Companies:
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National Health Research Institutes and National Health Research Institutes and Iowa State University and National Taiwan University
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Address:
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No. 35, Keyan Road, Zhunan Town,, Zhunan, 35053, Taiwan
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Keywords:
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Bridging Study ; Bayesian Approach ; Extrapolation ; Similarity
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Abstract:
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In this talk, we give some successful examples of bridging evaluation conducted in Taiwan. For evaluations of bridging studies, Liu, Hsiao and Hsueh (2002) have proposed a Bayesian approach to synthesize the data generated by bridging study and foreign clinical data generated in the original region for assessment of similarity based on superior efficacy of the test product over a placebo control. However, the results of the bridging studies using their method are overwhelmingly dominated by the results of the original region due to an imbalance of sample sizes between the regions. Therefore, we propose a Bayesian approach using a mixture prior for assessment of similarity between the new and original region based on the concept of positive treatment effect. Methods for sample size determination are proposed. Numerical examples illustrating uses of the proposed procedures are provided.
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