Multiregional Clinical Trials for Simultaneous Global New Drug Development: 1st Edition (e-Book) book cover

Multiregional Clinical Trials for Simultaneous Global New Drug Development

1st Edition

Edited by Joshua Chen, Hui Quan

Chapman and Hall/CRC

375 pages

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Hardback: 9781498701464
pub: 2016-04-01
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pub: 2016-04-21
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Description

In a global clinical development strategy, multiregional clinical trials (MRCTs) are vital in the development of innovative medicines. Multiregional Clinical Trials for Simultaneous Global New Drug Development presents a comprehensive overview on the current status of conducting MRCTs in clinical development. International experts from academia, in

Table of Contents

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.

About the Editors

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.

Subject Categories

BISAC Subject Codes/Headings:
MAT029000
MATHEMATICS / Probability & Statistics / General
MED071000
MEDICAL / Pharmacology
MED090000
MEDICAL / Biostatistics