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Activity Number: 247 - Clinical Trial Design- 2
Type: Contributed
Date/Time: Monday, July 30, 2018 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #330493 Presentation
Title: A Strategy for the Design and Analysis of Bridging Studies
Author(s): Eric Holmgren*
Companies: Beigene
Keywords: Bridging Study; Multi-Regional ; Clinical Trials; True Positive

Bridging studies are used to support registration of a new molecule in a specific country or region when there is a supporting Phase 3 trial that demonstrates the drug is effective in a general population. A variety of statistical methods have been proposed to analyze and size bridging studies. However these methods typically don't answer the question, is there enough evidence to support the effectiveness of the new drug in a specific country or region to the same degree that the associated Phase 3 trial supports the the effectiveness of the drug for its target population. In this paper we will attempt to address this question by considering what a bridging study would have to look like if it is desired to keep the ratio of true to false positives the same for the country or region under consideration as it is for the Phase 3 study population. In addition we show how this analysis can also be formulated as a Bayesian analysis and discuss how the associated prior may be ascertained from historical data. We also discuss internal bridging studies where the sub population of a Phase 3 trial is used to support approval in a specific country or region.

Authors who are presenting talks have a * after their name.

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