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Simultaneous Global New Drug Development

Multi-Regional Clinical Trials after ICH E17

By: Bruce Binkowitz (Editor), William Wang (Editor), Josh Chen (Editor), Hui Quan (Editor), Gang Li (Editor)

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Hardcover | 30 December 2021 | Edition Number 1

At a Glance

Hardcover
318 Pages

Dimensions(cm)
16.1 x 24.1 x 2.7

Hardcover

$588.75

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Global simultaneous development is becoming more necessary as the cost of developing medical products continues to grow. The strategy of using multiregional clinical trials (MRCTs) has become the preferred method for developing new medicines. Implementing the same protocol to include subjects from many geographical regions around the world, MRCTs can speed up the patient enrolment, thus resulting in quicker drug development and obtaining faster approval of the drug globally.

After the publication of the editors' first volume on this topic, there have been new developments on MRCTs. The International Council for Harmonisation (ICH) issued ICH E17, a guideline document on MRCTs, in November 2017, laying out principles on MRCTs. Beyond E17, new methodologies have been developed as well.

Simultaneous Global New Drug Development: Multi-Regional Clinical Trials after ICH E17 collects chapters providing interpretations of principles in ICH E17 and new ideas of implementing MRCTs. Authors are from different regions, and from academia and industry. In addition, in contrast to the first book, new perspectives are brought to MRCT from regulatory agencies.

This book will be of particular interest to biostatisticians working in late stage clinical development of medical products. It will also be especially helpful for statisticians in regulatory agencies, and medical research institutes.

This book is comprehensive across the MRCT topic spectrum, including

Issues regarding ICH E17 Implementation
MRCT Design and Analysis Methodologies
Perspectives from authorities in regulatory agencies, as well as statisticians practicing in the medical product industry
Many examples of real-life applications based on actual MRCTs.

Industry Reviews

"The book is valuable as it shares thought-provoking issues and considerations beyond a standard clinical trial. These extensions beyond standard methods would also be useful for qualified practising statisticians with reasonable technical expertise. The practical examples from various trials are also useful because these provide concrete examples and dilemmas which may also happen in real life."

"The book is a good starting point to assist practising statisticians in finding a solution, and as an information-sharing medium with examples from a number of case studies."

Steve Su, Australia, ISCB News, June 2022.

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