Multiregional Clinical Trials for Simultaneous Global New Drug Development

This book consolidates current state of knowledge regarding relevant topics on MRCTs (design, operation, and analysis/interpretation) into well-organized chapters. This book should serve as a useful source of information to anyone who plans to work or is working on MRCTs. There are many on-going challenges and we also hope it will stimulate further research in MRCTs.
~Nobushige Matsuoka, PhD and Norisuke Kawai, PhD, Pfizer Japan Inc.

" . . . Contributors to this book are among the best experts in their corresponding fields. . . Most chapters are short, with about 20 pages including references. This length of chapter makes the book easy to read and easy to follow. Concepts involving design, conduct, and analysis of MRCT are not simple, but this book successfully presents all of these topics—setting the stage and drilling down to a reasonable depth, without unnecessary detail. It also introduces many real world examples to help readers understand some of the difficult concepts. . . Each chapter introduces a stand-alone, self-contained topic. Cross-referencing of chapters is rarely needed, but is provided where appropriate. I learned a lot from this book, especially that issues arising in MRCT are much more difficult than issues in multi-center trials, from which much of my experience with clinical trials comes."
~Naitee Ting, Boehringer Ingelheim Pharmaceuticals, Inc.

"The editors have collected chapters and sections contributed by many authors, with each addressing a different important problem in global clinical development and MRCTs. The contributions to individual topics from academia, industry, and health authorities around the globe, strengthen the documentation greatly . . . I fully endorse the views of the editors that biostatisticians working in the area of randomized controlled trials in general, and MRCTs in particular, will find this book a useful reference."
~Sada Nand Dwivedi, International Society for Clinical Biostatistics

This book consolidates current state of knowledge regarding relevant topics on MRCTs (design, operation, and analysis/interpretation) into well-organized chapters. This book should serve as a useful source of information to anyone who plans to work or is working on MRCTs. There are many on-going challenges and we also hope it will stimulate further research in MRCTs.
~Nobushige Matsuoka, PhD and Norisuke Kawai, PhD, Pfizer Japan Inc.

" . . . Contributors to this book are among the best experts in their corresponding fields. . . Most chapters are short, with about 20 pages including references. This length of chapter makes the book easy to read and easy to follow. Concepts involving design, conduct, and analysis of MRCT are not simple, but this book successfully presents all of these topics—setting the stage and drilling down to a reasonable depth, without unnecessary detail. It also introduces many real world examples to help readers understand some of the difficult concepts. . . Each chapter introduces a stand-alone, self-contained topic. Cross-referencing of chapters is rarely needed, but is provided where appropriate. I learned a lot from this book, especially that issues arising in MRCT are much more difficult than issues in multi-center trials, from which much of my experience with clinical trials comes."
~Naitee Ting, Boehringer Ingelheim Pharmaceuticals, Inc.

"The editors have collected chapters and sections contributed by many authors, with each addressing a different important problem in global clinical development and MRCTs. The contributions to individual topics from academia, industry, and health authorities around the globe, strengthen the documentation greatly . . . I fully endorse the views of the editors that biostatisticians working in the area of randomized controlled trials in general, and MRCTs in particular, will find this book a useful reference."
~Sada Nand Dwivedi, International Society for Clinical Biostatistics