Chen / Quan Multiregional Clinical Trials for Simultaneous Global New Drug Development

Erscheinungsjahr 2016
ISBN: 978-1-4987-0148-8
Verlag: CRC Press
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 375 Seiten

Reihe: Chapman & Hall/CRC Biostatistics Series

Multi-regional clinical trials are often conducted as a single trial focusing on overall results. However, when such trials are submitted to health authorities, the scope and concern may broaden to include local results. Although this presents great opportunities, there are also tremendous challenges in the design, conduct, and interpretation of MRCTs. This book provides a collection of chapters contributed by various authors, each addressing a different aspect of the important problem in global clinical development and multi-regional clinical trials.

Zielgruppe

This book is intended for biostatisticians working in late stage clinical development of medical products. It also would be useful to statisticians and clinicians in the biopharmaceutical industry, regulatory agencies, and medical research institutes.

Autoren/Hrsg.

Chen, Joshua

Quan, Hui

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Epidemiologie, Medizinische Statistik
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie
• Mathematik | Informatik Mathematik Stochastik

Inhaltsverzeichnis

Simultaneous Global Development
The Journey to Multi-Regional Clinical Trials in Support of Simultaneous Global Product Development
Christy Chuang-Stein

Multi-Regional Clinical Trials for Simultaneous Global New Drug Development
Ekopimo Ibia and Bruce Binkowitz

Bridging Studies versus Multi-Regional Trials
Weichung J. Shih

MRCT: Design Considerations
Multi-Regional Clinical Trials: Assessing Consistency of Treatment Effect
Joshua Chen and Hongwei Wang

Regulatory Perspectives: Different Requirements/Endpoints and Needs for Harmonization
Cynthia J. Girman and Bruce Binkowitz

Intrinsic and Extrinsic Factors and Rationales to Be Considered When Defining Regions
Yoko Tanaka

Models and Sample Sizes for MRCTs
Hui Quan and Mingyu Li

Multi-Regional Clinical Trials in Oncology Drug Development
Mingxiu Hu

A Few More Considerations in Multi-Regional Clinical Trials on Regional Differences
Bo Yang and Yijie Zhou

Optimal Multi-Regional Clinical Trials
Zhaoyang Teng and Mark Chang

Implementation of Multi-Regional Clinical Trial Design
Xuezhou Mao and Mingyu Li

MRCT: DMC and Monitoring Regional Difference
Independent Data Monitoring Committees in Multi-Regional Clinical Trials
Janet Wittes

Monitoring Regional Difference based on Blinded Data in Multi-Regional Clinical Trials
Joshua Chen

Adaptive Multi-Regional Clinical Trials
Zhaoyang Teng and Mark Chang

MRCT: Analysis, Reporting, and Interpretation
Lessons Learned and Recommendations Regarding Multi-Regional Clinical Trials from a Well-Practiced Industry Statistician
Bruce Binkowitz

Quantification of Regional Treatment Effects for MRCTs
Hui Quan and Xuezhou Mao

Multi-Regional Clinical Trials: Country Specific Assessment
Joshua Chen and Xuezhou Mao

A Case Study: Multiregional Outcome Trial for a Multivalent Human Papillomavirus Vaccine
Oliver Bautista, Erin Moeller, and Alain Luxembourg

MRCT: Latest Development and Trend
Alternative Random-Effects Model: The Discrete Random Effects Model (DREM) - Assessing Benefit and Consistency of Treatment Effect under DREM
Hsiao-Hui Tsou, K.K. Gordon Lan, Jung-Tzu Liu, and Chin-Fu Hsiao

New Drug Development Paradigms in China-Simultaneous Global Drug Development Program
Gang Chen, Qin Huang, Frank Shen, Zhilong Yuan, and Dayao Zhao

Special Considerations for Emerging Markets
Gang Li and Jun Zhao

A Predictive Bayesian Approach to the Design and Analysis of Bridging Studies
A. Lawrence Gould and William W.B. Wang

Multi-Regional Clinical Trial: Japanese Viewpoint

Madoka Takeuchi and Masahiro Takeuchi

Special Considerations for Medical Devices: An Overview

Yunling Xu, Nelson Lu, Gerry Gray

Use of Multinational Randomized Clinical Trials in Economic Evaluations of Health Care

Joseph Heyse, Jieling Chen, and John Cook

Regional Benefit and Risk Evaluations

Über Autor(innen)

Dr. Yonghua (Joshua) Chen is the Global Head of Biostatistics and Programming at Sanofi Pasteur. He received his PhD in statistics from the University of Wisconsin–Madison. He previously worked on clinical development of small molecules, biologics, and vaccines at Merck Research Laboratory Labs. His experience spans many therapeutic areas with a major focus on human vaccines and antiviral drugs. He has extensive experience in study design, conducting, and reporting international clinical trials from proof-of-concept through regulatory approvals and life cycle management. His primary research interest is clinical trial designs, including group sequential methods, adaptive designs, and multi-regional clinical trials (MRCTs). He was a co-lead of the cross-industry MRCT Consistency Working Group under PhRMA (2008–2011) and Society for Clinical Trials (2012–2014).

Dr. Hui Quan is the Associate VP and Global Head of the Methodology Group in the Biostatistics and Programming Department of Sanofi Pasteur. He received his PhD in statistics from Columbia University. A fellow of the American Statistical Association, he has 24 years of pharmaceutical industry experience in many therapeutic areas ranging from early phase to Phase IV studies. He has published 82 papers, including 59 statistical papers. His research interests include multivariate analysis, safety analysis, multiplicity adjustment, missing handling, adaptive design, integrated data analysis, modeling and simulation, benefit/risk assessment, and multi-regional clinical trials (MRCTs). He served as a co-leader of the MRCT Consistency Assessment Working Group under PhRMA (2008–2011) and Society for Clinical Trials (2012–2014).