Main description:

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.

Contents:

Bridging Diversity: Extrapolating Foreign Data to a New Region. Two-Stage Designs of Bridging Studies. Consistency of Treatment Effects in Bridging Studies and Global Multiregional Trials. Assessing Similarity Using the Reproducibility and Generalizability Probabilities and the Sensitivity Index. Combining Information in Clinical Drug Development: Bridging Studies and Beyond. A Bayesian Approach for Evaluation of Bridging Studies. Issues of Sample Size in Bridging Trials and Global Clinical Trials. Design and Sample Size Considerations for Global Trials. Application of Genomic Technologies for Bridging Strategy Involving Different Race and Ethnicity in Pharmacogenomics Clinical Trials. Interaction Effects in Bridging Studies. Multiregional Clinical Trials. Multiregional Clinical Trials for Global Simultaneous Drug Development in Japan. Feasibility and Implementation of Bridging Studies in Taiwan. Index.