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Design and analysis of clinical trials : concepts and methodologies

Praise for the Second Edition: "...a grand feast for biostatisticians. It stands ready to satisfy the appetite of any pharmaceutical scientist with a respectable statistical appetite." 'Journal of Clinical Research Best Practices The Third Edition of Design and Analysis of Clinical Trials provides complete, comprehensive, and expanded coverage of recent health treatments and interventions. Featuring a unified presentation, the book provides a well-balanced summary of current regulatory requirements and recently developed statistical methods as well as an overview of the various designs and analyses that are utilized at different stages of clinical research and development. Additional features of this Third Edition include: New chapters on biomarker development and target clinical trials, adaptive design, trials for evaluating diagnostic devices, statistical methods for translational medicine, and traditional Chinese medicine A balanced overview of current and emerging clinical issues as well as newly developed statistical methodologies Practical examples of clinical trials that demonstrate everyday applicability, with illustrations and examples to explain key concepts New sections on bridging studies and global trials, QT studies, multinational trials, comparative effectiveness trials, and the analysis of QT/QTc prolongation A complete and balanced presentation of clinical and scientific issues, statistical concepts, and methodologies for bridging clinical and statistical disciplines An update of each chapter that reflects changes in regulatory requirements for the drug review and approval process and recent developments in statistical design and methodology for clinical research and development Design and Analysis of Clinical Trials, Third Edition continues to be an ideal clinical research reference for academic, pharmaceutical, medical, and regulatory scientists/researchers, statisticians, and graduate-level students.

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  • "Praise for the Second Edition: "...a grand feast for biostatisticians. It stands ready to satisfy the appetite of any pharmaceutical scientist with a respectable statistical appetite." 'Journal of Clinical Research Best Practices The Third Edition of Design and Analysis of Clinical Trials provides complete, comprehensive, and expanded coverage of recent health treatments and interventions. Featuring a unified presentation, the book provides a well-balanced summary of current regulatory requirements and recently developed statistical methods as well as an overview of the various designs and analyses that are utilized at different stages of clinical research and development. Additional features of this Third Edition include: New chapters on biomarker development and target clinical trials, adaptive design, trials for evaluating diagnostic devices, statistical methods for translational medicine, and traditional Chinese medicine A balanced overview of current and emerging clinical issues as well as newly developed statistical methodologies Practical examples of clinical trials that demonstrate everyday applicability, with illustrations and examples to explain key concepts New sections on bridging studies and global trials, QT studies, multinational trials, comparative effectiveness trials, and the analysis of QT/QTc prolongation A complete and balanced presentation of clinical and scientific issues, statistical concepts, and methodologies for bridging clinical and statistical disciplines An update of each chapter that reflects changes in regulatory requirements for the drug review and approval process and recent developments in statistical design and methodology for clinical research and development Design and Analysis of Clinical Trials, Third Edition continues to be an ideal clinical research reference for academic, pharmaceutical, medical, and regulatory scientists/researchers, statisticians, and graduate-level students."@en
  • "Presentation of principles and methodologies for various clinical trials, and a well-balanced summary of current regulatory requirements. Emphasizes real-life examples and illustrations from clinical case studies, as well as numerous references."@en
  • "Praise for the First Edition of "Design and Analysis of Clinical Trials" "An excellent book, providing a discussion of the clinical trial process from designing the study through analyzing the data, and to regulatory requirement ... could easily be used as a classroom text to understand the process in the new drug development area."--"Statistical Methods in Medicine" A complete and balanced presentation now revised, updated, and expanded As the field of research possibilities expands, the need for a working understanding of how to carry out clinical trials only increases. New developments in the theory and practice of clinical research include a growing body of literature on the subject, new technologies and methodologies, and new guidelines from the International Conference on Harmonization (ICH). "Design and Analysis of Clinical Trials," Second Edition provides both a comprehensive, unified presentation of principles and methodologies for various clinical trials, and a well-balanced summary of current regulatory requirements. This unique resource bridges the gap between clinical and statistical disciplines, covering both fields in a lucid and accessible manner. Thoroughly updated from its first edition, the Second Edition of "Design and Analysis of Clinical Trials" features new topics such as: Clinical trials and regulations, especially those of the ICH Clinical significance, reproducibility, and generalizability Goals of clinical trials and target population New study designs and trial types Sample size determination on equivalence and noninferiority trials, as well as comparing variabilities Also, three entirely new chapters cover: Designs for cancerclinical trials Preparation and implementation of a clinical protocol Data management of a clinical trial Written with the practitioner in mind, the presentation assumes only a minimal mathematical and statistical background for its reader. Instead, the writing emphasizes real-life examples and illustrations from clinical case studies, as well as numerous references-280 of them new to the Second Edition-to the literature. "Design and Analysis of Clinical Trials," Second Edition will benefit academic, pharmaceutical, medical, and regulatory scientists/researchers, statisticians, and graduate-level students in these areas by serving as a useful, thorough reference source for clinical research."@en
  • "Praise for the First Edition of Design and Analysis of Clinical Trials. "An excellent book, providing a discussion of the clinical trial process from designing the study through analyzing the data, and to regulatory requirement ... could easily be used as a classroom text to understand the process in the new drug development area.". - Statistical Methods in Medicine. A complete and balanced presentation now revised, updated, and expanded. As the field of research possibilities expands, the need for a working understanding of how to carry out clinical trials only increases. New deve."@en
  • "Praise for the Second Edition: " ... a grand feast for biostatisticians. It stands ready to satisfy the appetite of any pharmaceutical scientist with a respectable statistical appetite."--Journal of Clinical Research Best Practices The Third Edition of Design and Analysis of Clinical Trials provides complete, comprehensive, and expanded coverage of recent health treatments and interventions. Featuring a unified presentation, the book provides a well-balanced summary of current regulatory requirements and recently developed statistical methods as well as."

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  • "Electronic resource"@en
  • "Livres électroniques"
  • "Electronic books"
  • "Electronic books"@en

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  • "Design and analysis of clinical trials : concepts and methodologies"@en
  • "Design and analysis of clinical trials : concepts and methodologies"
  • "Design and Analysis of Clinical Trials Concepts and Methodologies. Wiley Series in Probability and Statistics"@en
  • "Design and Analysis of Clinical Trials Concepts and Methodologies"@en
  • "Design and Analysis of Clinical Trials Concepts and Methodologies"
  • "Design and analysis of clinical trials concepts and methodologies"@en
  • "Design and analysis of clinical trials concepts and methodologies"
  • "Design and analysis of clinical trials"@en
  • "Design and analysis of clinical trials concept and methodologies"
  • "Design and analysis of clinical trials concept and methodologies"@en
  • "Design and analysis of clinical trials : concept and methodologies"

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