JSM 2004 - Toronto

Abstract #300436

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Activity Number: 305
Type: Contributed
Date/Time: Wednesday, August 11, 2004 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #300436
Title: A Group Sequential Approach to Evaluation of Bridging Studies
Author(s): Chin-Fu Hsiao*+
Companies: National Health Research Institutes
Address: 128 Yen-Chiu-Yuan Rd. Sec. 2, Taipei, International, 115, Taiwan, ROC
Keywords: bridging study ; extrapolation ; group sequential analysis ; 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 due to its proven efficacy and safety. 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 is the information on efficacy, safety, dosage, and dose regimen of the original region cannot be concurrently obtained from the local bridging studies but available in the trials conducted in the original region. A group sequential approach is therefore proposed to overcome the issue of internal validity. In particular, we use the region as group sequence to enroll the patients from the original region first and then to enroll patients from the new region subsequently.

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