Simultaneous Global New Drug Development: Multi-Regional Clinical Trials after ICH E17

Global simultaneous development of medical products is becoming increasingly important due to rising costs. Multiregional clinical trials (MRCTs) are the preferred method for developing new medicines, as they can speed up patient enrolment and obtain faster approval globally. The International Council for Harmonisation (ICH) issued ICH E17, a guideline document on MRCTs, in November 2017. This book discusses new developments on MRCTs, including interpretations of principles in ICH E17 and new ideas for implementing MRCTs. It is comprehensive across the MRCT topic spectrum and will be of particular interest to biostatisticians, statisticians in regulatory agencies, and medical research institutes.

Format: Paperback / softback
Length: 302 pages
Publication date: 29 January 2024
Publisher: Taylor & Francis Ltd

The demand for global simultaneous development of medical products is increasing due to the soaring costs associated with their development. As a result, multiregional clinical trials (MRCTs) have emerged as the preferred strategy for creating new medicines. MRCTs involve implementing the same protocol across multiple geographical regions, allowing for faster patient enrolment and ultimately expediting drug development and global approval.

In recent years, significant advancements have been made in the field of MRCTs. In November 2017, the International Council for Harmonisation (ICH) released ICH E17, a guideline document that provides principles and guidance for conducting MRCTs. Since then, new methodologies and perspectives have emerged, contributing to the ongoing development of this approach.

The book "Simultaneous Global New Drug Development: Multi-Regional Clinical Trials after ICH E17" aims to provide a comprehensive overview of MRCTs. It comprises chapters authored by experts from various regions, including academia and industry. The book explores different aspects of MRCTs, including issues related to the implementation of ICH E17, MRCT design and analysis methodologies, perspectives from regulatory agencies, and statisticians working in the medical product industry.

One of the key strengths of this book is its practical focus. It offers numerous real-life examples of MRCTs that have been conducted in different therapeutic areas, providing valuable insights into the practical application of this approach. These examples serve as a valuable resource for biostatisticians, statisticians, and professionals involved in late-stage clinical development of medical products.

Furthermore, the book addresses the challenges and considerations associated with MRCTs, such as ensuring data quality and integrity, addressing cultural and linguistic differences, and navigating regulatory complexities. By addressing these challenges, the book empowers professionals to effectively implement MRCTs and contribute to the global development of innovative medicines.

In conclusion, "Simultaneous Global New Drug Development: Multi-Regional Clinical Trials after ICH E17" is a valuable resource for professionals involved in the development of medical products. It provides a comprehensive understanding of MRCTs, their principles, methodologies, and real-life applications. The book's practical focus and comprehensive coverage make it an essential tool for advancing global drug development and improving patient outcomes.

Weight: 453g
Dimension: 234 x 156 (mm)
ISBN-13: 9780367625795