Description
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.
Table of Contents
Chapter 1: General Introduction of E17
Yoshiaki Uyama, Yasuto Otsubo, Shuji Kamada, Yoko Aoi
Chapter 2: New Principles in Global development using ICH E 17 guideline
Vibeke Bjerregaard, Rominder Singh
Chapter 3: Consideration of "Ethnic Factors" as Defined in ICH E5 for Drug Development and Application in ICH E17 Guidelines for Conduct of Multiregional Clinical Trials (MRCT)
Rominder Singh, Vibeke Bjerregaard
Chapter 4: Pooling Strategy
Osamu Komiyama, Shintaro Hiro, Nobushige Matsuoka, Hideharu Yamamoto
Chapter 5: Overall sample size and allocation to regions
Aloka Chakravarty, Xin Zeng, William Wang
Chapter 6: Consistency Evaluation in MRCTs
William Wang, Armin Koch, Osamu Komiyama
Chapter 7: Implementation of the ICH E17 guideline in Japan
Yoshiaki Uyama, Yasuto Otsubo, Shuji Kamada, Yoko Aoi
Chapter 8: ICH E17 and MRCT: Implementation and Regulatory Perspective in China
Xin Zeng, Jun Wang, Zhaoyun Wang, Zhimin Yang,Min Li
Chapter 9: Lessons Learned from Actual Multi-regional Clinical Trials with Signals of Treatment Effect Heterogeneity
Bruce Binkowitz, Gang Li, Hui Quan, Gordon Lan, Soo Peter Ouyang, Weining Robieson, William Wang, Sammy Yuan, Yoko Tanaka, Josh Chen, Lanju Zhang, Paul Gallo
Chapter 10: Leveraging Foreign Clinical Data Extrapolation to Accelerate Global Drug Development: A Case Study in Hematological Oncology
Hongjie Zhu, Jingjing Ye, Xiang Guo
Chapter 11: Analysis Models for Multi-regional Clinical Trials
Gang Li, Hui Quan, Gordon KK Lan
Chapter 12: Utilization of Robust Estimates of Treatment Effects via Semi-Parametric Models in MRCT
Ming Tan, Shilin Yu, Ao Yuan
Chapter 13: Hierarchical Linear Models for Multi-Regional Clinical Trials
Seung-Ho Kang, Saemina Kim
Chapter 14: Local Treatment Effect Estimation by Borrowing Information from Similar Regions in Multi-Regional Clinical Trials
Hua Guo, Josh Chen, Hui Quan
Chapter 15: Global Drug Development: Multi-Regional Clinical Trials (MRCTs) – China’s Pursuit
Joe Shih, Tai Xie, Kun He
Chapter 16: Statistical considerations in MRCT design and analysis
Lanju Zhang, Weining Z Robieson
Chapter 17: Multiple Endpoints in Multiregional Clinical Trials
Toshimitsu Hamasaki, Yuh-Jenn Wu, Chinfu Hisio
Chapter 18: Multiregional Clinical Trials with Heterogeneous Regional and Treatment Effects
Hsiao-Hui Tsou, Yu-Chieh Cheng, K.K. Gordon Lan, Hsiao-Yu Wu, Ya-Ting Hsu, Fang-Jing Lee, Chi-Tian Chen, Meng-Hsuan Wu, Chin-Fu Hsiao
Chapter 19: Regional sample size calculation in multiregional equivalence and non-inferiority trials
Jason Liao, Yaru Shi, Ziji Yu
