Design and Analysis of Clinical Trials – Concepts and Methodologies, Third Edition 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.

The book can be distinguished from the first two editions in two ways.  First, the authors have revised and/or updated each chapter to reflect changes in regulatory requirements for drug review/approval process and recent development in statistical design and methodology in clinical research and development.  Second, additional sections on global (or multi-national or multi-regional) trials, design and analysis of QT/QTc studies, and comparative effectiveness trials are included.  With the inclusion of five new chapters, this book is a more complete and comprehensive reference source for clinical scientists and/or biostatisticians.  The Third Edition provides complete and comprehensive coverage and includes new topics such as biomarker development for target clinical trials, the use of adaptive methods in clinical trials, trials for evaluating diagnostic devices, statistical methods in translational research/science and medicine, and issues in traditional Chinese medicine. Within the new chapter on biomarker development and targeted clinical trials, the concepts and strategies of the development for targeted drugs as well as development and validation of diagnostic devices based on biomarkers are addressed. In addition, statistical methods design and analysis of targeted clinical trials are covered with consideration of the uncertainty and inaccuracy of diagnostic devices. All methodologies are illustrated through real targeted clinical trials such as TAILORx trials, ALTTO trials, and MINDACT trials. Several commonly employed adaptive designs such as adaptive dose finding design, seamless adaptive design, and drop-the-loser design are introduced.  Statistical strategies for handling operational biases and methods for controlling the overall type I error rate are also discussed.   The design and analysis for evaluation diagnostic devices is presented with special attentions to the Bayesian approaches to evaluation of diagnostic devices. The US FDA guidance on reporting results from diagnostic trials is also reviewed, and methods for the sample size determination for diagnostic trials are provided.   In addition, statistical methods for assessment of the probability of success, lost-in-translation in the one-way/two-way translational process, and determination of whether an animal model is predictive of a human model are introduced.   Practical issues and statistical considerations for the assessment traditional Chinese medicine are discussed as are statistical tests for consistency and stability analysis of TCMs. 

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.