Design and Analysis of Bridging Studies

Jen-pei Liu, Shein-Chung Chow, Chin-Fu Hsiao

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July 26, 2012 by Chapman and Hall/CRC
Professional - 287 Pages - 23 B/W Illustrations
ISBN 9781439846346 - CAT# K12075
Series: Chapman & Hall/CRC Biostatistics Series

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Features

  • Represents the first book completely devoted to the design and analysis of bridging studies
  • Presents sample size calculations in bridging studies
  • Includes the statistical inference of bridging studies in multiregional clinical trials for global drug development
  • Applies genomic technologies to bridging studies
  • Explores possible interaction/confounding effects in bridging studies
  • Examines the impact of special populations in bridging studies

Summary

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 Studies addresses 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.