Design and Analysis of Bridging Studies [Hardcover]

As the development of medicines has become more globalized, the geographic variations in the efficacy and safety of pharmaceutical products need to be addressed. To accelerate the product development process and shorten approval time, researchers are beginning to design multiregional trials that incorporate subjects from many countries around the world under the same protocol.

Design and Analysis of Bridging Studiesaddresses the issues arising from bridging studies and multiregional clinical trials. For bridging studies, the book explores ethnic sensitivity, the necessity of bridging studies, types of bridging studies, and the assessment of similarity between regions based on bridging evidence. For multiregional clinical trials, the text considers regional differences, assesses the consistency of treatment effect across regions, and discusses sample size determination for each region.

Taking into account the International Conference Harmonisation (ICH) E5 framework for bridging studies, the book provides a unified summary of the growing literature and research activities in this area. It covers the regulatory requirements, scientific and practical issues, and statistical methodology for designing and evaluating bridging studies and multiregional clinical trials, with the goal of inspiring new research activities in the field.

Bridging Diversity: Extrapolating Foreign Data to a New Region, Shein-Chung Chow and Chin-Fu Hsiao
Introduction
Impact of Ethnic Differences
Regulatory Guidelines
Current Issues
Examples
Concluding Remarks
Aim and Structure of the Book

Two-Stage Designs of Bridging Studies, Chin-Fu Hsiao, Hsiao-Hui Tsou, Jen-pei Liu, and Yuh-Jenn Wu
Introduction
Two-Stage Design for Bridging Studies
Group Sequential Approach to Evaluating BridlÃ(