JSM 2005 Online Program

Abstract #303084

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Activity Number:	266
Type:	Contributed
Date/Time:	Tuesday, August 9, 2005 : 10:30 AM to 12:20 PM
Sponsor:	Biopharmaceutical Section
Abstract - #303084
Title:	Use of Prior Distributions for Bayesian Evaluation of Bridging Studies
Author(s):	Chinfu Hsiao*+ and Jen-Pei Liu and Yu-Yi Hsu
Companies:	National Health Research Institutes and National Taiwan University and National Health Research Institutes
Address:	No 35 Keyan Road Zhunan Town, Miaoli County, 350, Taiwan
Keywords:	Bridging Study ; Bayesian Approach ; Extrapolation ; Similarity
Abstract:	The ICH E5 guideline defines a bridging study as a supplementary study conducted in the new region to provide pharmacodynamic or clinical data on efficacy, safety, dosage, and dose regimen to allow extrapolation of the foreign clinical data to the population of the new region. Therefore, a bridging study is usually conducted in the new region only after the test product has been approved for commercial marketing in the original region based on its proven efficacy and safety. In this paper, we address the issue of analysis of clinical data generated by the bridging study conducted in the new region to evaluate the similarity for extrapolation of the foreign clinical data to the population of the new region. Information on efficacy, safety, dosage, and dose regimen of the original region cannot be obtained concurrently from the local bridging studies, but is available in the trials conducted in the original region. Liu, Hsiao, and Hsueh (2002) proposed a Bayesian approach to synthesize the data generated by the 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.

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