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Book Review: Design and Analysis of Bridging Studies, edited by J. P. Liu, S. C. Chow, and C. F. Hsiao

To accelerate pharmaceutical product development globally, the research and application of bridging studies and/or multiregional clinical trials (MRCTs) have increased significantly in recent years. Many publications have appeared and many scientific workshops have been held on this topic, but there has been a lack of systematic review on the statistical methodology, regulatory requirement, and practical implementation. This is the first book to fill the gap. This book not only provides a comprehensive review of the growing literatures and research activities, but also sheds light on new strategic and research directions. Throughout the book chapters, many real examples or simulation studies are used to illustrate the concepts, which makes the contents relevant for the readers and easier to understand. Although the title of this book only refers to bridging studies, the content covers well beyond the classical bridging strategy. The book is edited and contributed to by leading experts from academic institutions, regulatory agencies, and pharmaceutical companies across the globe. Despite many authors and some overlap across chapters, the book is organized cohesively: Chapter 1 provides the basic background and bridging framework of extrapolating foreign data to a new region in pharmaceutical research and development. A high-level review of the regulatory guidance from the International Conference on Harmonization (ICH) and the Japanese Ministry of Health, Labor and Welfare (MHLW) are briefly covered. Chapter 2 introduces a classical group sequential design and a more flexible two-stage design to synthesize the data from both the bridging study and the original region. Chapter 3 discusses the assessment of consistency between the original region and the new region under the settings of bridging studies and MRCTs. Chapter 4 covers multiple approaches of assessing similarity based on the concepts of reproducibility, generalizability, and sensitivity index. Chapter 5 focuses on the weighted Z method to combine information from different regions. Alternatively, Chapter 6 introduces a Bayesian approach to analyzing data in the new region while leveraging information from the foreign regions. Chapters 7 and 8 provide a comprehensive overview of statistical methods in the bridging studies and MRCTs, with a strong focus on the sample size determination and the impact of regional heterogeneity. In addition, many design issues from the clinical, regulatory, commercial, and operational perspectives are also included. Chapter 9 discusses the pharmacogenomics bridging strategy that leverages the growing genomic technology