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Full 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
Contents
1. General Introduction of E17. 2. New Principles in Global development using ICH E 17 guideline. 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). 4. Pooling Strategy. 5. Overall sample size and allocation to regions. 6. Consistency Evaluation in MRCTs. 7. Implementation of the ICH E17 guideline in Japan. 8. ICH E17 and MRCT: Implementation and Regulatory Perspective in China. 9. Lessons Learned from Actual Multi-regional Clinical Trials with Signals of Treatment Effect Heterogeneity. 10. Leveraging Foreign Clinical Data Extrapolation to Accelerate Global Drug Development: A Case Study in Hematological Oncology. 11. Analysis Models for Multi-regional Clinical Trials. 12. Utilization of Robust Estimates of Treatment Effects via Semi-Parametric Models in MRCT. 13. Hierarchical Linear Models for Multi-Regional Clinical Trials. 14. Local Treatment Effect Estimation by Borrowing Information from Similar Regions in Multi-Regional Clinical Trials. 15. Global Drug Development: Multi-Regional Clinical Trials (MRCTs) - China's Pursuit. 16. Statistical considerations in MRCT design and analysis. 17. Multiple Endpoints in Multiregional Clinical Trials. 18. Multiregional Clinical Trials with Heterogeneous Regional and Treatment Effects. 19. Regional sample size calculation in multiregional equivalence and non-inferiority trials
