Multiregional Clinical Trials for Simultaneous Global New Drug Development

ISBN-13: 9780367737221 / Angielski / Miękka / 2020 / 353 str.

Joshua Chen; Hui Quan

Opis

This book presents a comprehensive overview on the current status of conducting MRCTs in clinical development. It first provides a high-level introduction to the context, motivation, opportunities, and challenges in simultaneous global clinical development using MRCTs. It then focuses on the design, monitoring, and analysis/interpretation of MRC

Spis treści

Simultaneous Global Development. Multiregional Clinical Trial: Design Considerations. Multiregional Clinical Trial: Data Monitoring Committee and Monitoring Regional Difference. Multiregional Clinical Trial: Analysis, Reporting, and Interpretation. Multiregional Clinical Trial: Latest Development and Trend. Index.

O autorze

Joshua Chen is the global head of biostatistics and programming at Sanofi Pasteur. He previously worked on clinical development of small molecules, biologics, and vaccines at Merck Research Laboratories. His experience spans many therapeutic areas with a major focus on human vaccines and antiviral drugs. He has extensive experience in the study, design, conducting, and reporting of 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 multiregional clinical trials (MRCTs). Dr. Chen was a colead of the cross-industry MRCT Consistency Working Group under PhRMA (2008–2011) and the Society for Clinical Trials (2012–2014). He earned his PhD in statistics from the University of Wisconsin–Madison.

Hui Quan is an associate vice president and global head of the methodology group in the Biostatistics and Programming Department of Sanofi–Aventis. 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 MRCTs. Dr. Quan was a colead of the MRCT Consistency Assessment Working Group under PhRMA (2008–2011) and the Society for Clinical Trials (2012–2014). He earned his PhD in statistics from Columbia University.