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Title Multiregional clinical trials for simultaneous global new drug development / edited by Joshua Chen, Merck Research Laboratories, Late Development Statistics, and Hui Quan, Sanofi Aventis Group, Clinical Sciences and Operations.
Imprint Roca Raton, FL : CRC Press, Taylor & Francis Group, [2016]
©2016

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Description 1 online resource (xxii, 341 pages) : illustrations
Series Chapman & Hall/CRC biostatistics series
Chapman & Hall/CRC biostatistics series.
Note "A Chapman & Hall book."
Bibliog. Includes bibliographical references and index.
Note Available only to authorized UTEP users.
Print version record.
Subject Drug development.
Clinical trials.
Drugs -- Testing.
Contents Simultaneous global development -- Multiregional clinical trial : design considerations -- Multiregional clinical trial : data monitoring committee and monitoring regional differences -- Multiregional clinical trial : analysis, reporting, and interpretation -- Multiregional clinical trial : latest development and trends.
Machine generated contents note: Section I Simultaneous Global Development -- 1.The Journey to Multiregional Clinical Trials in Support of Simultaneous Global Product Development / Christy Chuang-Stein -- 2.General Principles and Considerations in Multiregional Clinical Trials for Simultaneous Global New Drug Development / Bruce Binkowitz -- 3.Bridging Studies versus Multiregional Trials / Weichung J. Shih -- Section II Multiregional Clinical Trial: Design Considerations -- 4.Multiregional Clinical Trials: Assessing Consistency of Treatment Effect / Hongwei Wang -- 5.Regulatory Perspectives: Different Requirements/Endpoints and Needs for Harmonization / Bruce Binkowitz -- 6.Intrinsic and Extrinsic Factors and Rationales to Be Considered When Defining Regions / Yoko Tanaka -- 7.Models and Sample Sizes for Multiregional Clinical Trials / Mingyu Li -- 8.Multiregional Clinical Trials in Oncology Drug Development / Mingxiu Hu
Note continued: 9.A Few More Considerations in Multiregional Clinical Trials on Regional Differences / Yijie Zhou -- 10.Optimal Multiregional Clinical Trials / Mark Chang -- 11.Implementation of Multiregional Clinical Trial Design / Mingyu Li -- Section III Multiregional Clinical Trial: Data Monitoring Committee and Monitoring Regional Differences -- 12.Independent Data Monitoring Committees in Multiregional Clinical Trials / Janet Wittes -- 13.Monitoring Regional Differences Based on Blinded Data in Multiregional Clinical Trials / Joshua Chen -- 14.Adaptive Multiregional Clinical Trials / Mark Chang -- Section IV Multiregional Clinical Trial: Analysis, Reporting, and Interpretation -- 15.Lessons Learned and Recommendations Regarding Multiregional Clinical Trials from a Well-Practiced Industry Statistician / Bruce Binkowitz -- 16.Quantification of Regional Treatment Effects for Multiregional Clinical Trials / Xuezhou Mao
Note continued: 17.Multiregional Clinical Trials: Country-Specific Assessment / Xuezhou Mao -- 18.Multiregional Outcome Trial for a Multivalent Human Papillomavirus Vaccine: A Case Study / Alain Luxembourg -- Section V Multiregional Clinical Trial: Latest Development and Trends -- 19.The Discrete Random-Effects Model -- Assessing Benefit and Consistency of Treatment Effect / Chin-Fu Hsiao -- 20.New Drug Development Paradigms in China: Simultaneous Global Drug Development Program / Dayao Zhao -- 21.Special Considerations for Emerging Markets / Jun Zhao -- 22.A Predictive Bayesian Approach to the Design and Analysis of Bridging Studies / William W. B. Wang -- 23.Multiregional Clinical Trial: A Japanese Viewpoint / Masahiro Takeuchi -- 24.Special Considerations for Medical Devices: An Overview / Gerry Gray -- 25.Use of Multinational Randomized Clinical Trials in Economic Evaluations of Health Care / John R. Cook -- 26.Regional Benefit and Risk Evaluations / Hui Quan.
Other Author Chen, Joshua, editor.
Quan, Hui, 1972- editor.
Other Title Print version: Multiregional clinical trials for simultaneous global new drug development. Boca Raton : CRC Press, Taylor & Francis Group, [2016] 9781498701464