| Description |
1 online resource (xxii, 341 pages) : illustrations |
| Series |
Chapman & Hall/CRC biostatistics series |
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Chapman & Hall/CRC biostatistics series
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| 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 |
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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 |
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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 |
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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 |
| Notes |
"A Chapman & Hall book." |
| Bibliography |
Includes bibliographical references and index |
| Notes |
Print version record |
| Subject |
Drug development.
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Clinical trials.
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Drugs -- Testing.
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Clinical Trials as Topic -- methods
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Drug Approval -- methods
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Clinical Trials as Topic
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Internationality
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MEDICAL -- Pharmacology.
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Clinical trials
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Drug development
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Drugs -- Testing
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| Form |
Electronic book
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| Author |
Chen, Joshua, editor
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Quan, Hui, 1972- editor
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| ISBN |
9781498701488 |
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1498701485 |
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9780429172274 |
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0429172273 |
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