Evaluation of the Strength of Bridging Evidence

• Activity Number: 394
• Type: Topic Contributed
• Date/Time: Tuesday, August 3, 2010 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Hsiao-Hui Tsou* and Jung-Tzu Liu and Chin-Fu Hsiao and Yi Tsong+
• Companies: National Health Research Institutes, Taiwan and National Health Research Institutes, Taiwan and National Health Research Institutes, Taiwan and CDER/FDA
• Keywords: Bridging study ; Non-inferiority bridging ; Weighted evidence

Abstract

The conventional non-inferiority criterion requires the treatment effect attained in the new region preserves a pre-specified proportion of the treatment effect attained in the original region. Hsiao et al (2007) proposed a Bayesian approach that borrows the strength of the original trial to establish the treatment effect in the bridging region through using a weighted prior distribution. In this presentation, we consider the overall treatment effect by combining the weighted effects attained in the original and bridging region. The maximum weight allowed to be placed on the estimate of bridging region in order to show significant overall treatment effect represents the strength of the treatment effect in the bridging region. Regional approval will be evaluated by either comparing the weight estimate with the pre-specified limit or based on benefit-risk evaluation of the medicine.