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9781032093505

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This is the first edition of a comprehensive book covering the most recent methodology on innovative clinical trial designs for drugs and biological products. It is a great reference book for statisticians, clinicians, and other stakeholders involved in drug discovery and development. ... Chang et al aimed to provide the statistical framework to reach the overall development program optimizations in this book. In addition, innovative methodology to mitigate the risks of failed efficacy, safety, strategy, commercial and operation failures have been described by Chang et al. Special techniques such as clinical trial simulations are highly recommended by the authors. .... In summary, this is an excellent reference book for statisticians, clinicians, and all stakeholders involved in clinical development program with a common goal to reach clinical development optimization. -Holly Huang in the Journal of Biopharmaceutical Statistics, October 2019 The book has a number of detailed examples, and SAS and R code to implement some of the methods described in the text...In summary, this book covers a wide range of interesting topics in clinical trials, and provides an appealing and useful reference to researchers. - Ionut Bebu, JASA 2020 This first edition of this book provides the most recent methodology and statistical considerations in the design and management of clinical trials. It is focused on professionals in drug development, specifically statisticians and clinical researchers...It is, however, a useful insight into strategies for specific situations including personalized medicine, missing data, adaptive design, and multiple testing. The authors include a large number of practical clinical trials from various therapeutic areas, and they put emphasis on the use of clinical trial simulations...The authors present a remarkable amount of SAS code examples that could be directly used in daily practice. An extensive overview of modern innovative strategies for clinical trials helps to broaden the horizons of scientists interested in drug or treatment development. - Iveta Selingerova, ISCB News, July 2020

""This is the first edition of a comprehensive book covering the most recent methodology on innovative clinical trial designs for drugs and biological products. It is a great reference book for statisticians, clinicians, and other stakeholders involved in drug discovery and development. ... Chang et al aimed to provide the statistical framework to reach the overall development program optimizations in this book. In addition, innovative methodology to mitigate the risks of failed efficacy, safety, strategy, commercial and operation failures have been described by Chang et al. Special techniques such as clinical trial simulations are highly recommended by the authors. .... In summary, this is an excellent reference book for statisticians, clinicians, and all stakeholders involved in clinical development program with a common goal to reach clinical development optimization.” —Holly Huang in the Journal of Biopharmaceutical Statistics, October 2019 ""The book has a number of detailed examples, and SAS and R code to implement some of the methods described in the text...In summary, this book covers a wide range of interesting topics in clinical trials, and provides an appealing and useful reference to researchers."" - Ionut Bebu, JASA 2020 ""This first edition of this book provides the most recent methodology and statistical considerations in the design and management of clinical trials. It is focused on professionals in drug development, specifically statisticians and clinical researchers...It is, however, a useful insight into strategies for specific situations including personalized medicine, missing data, adaptive design, and multiple testing. The authors include a large number of practical clinical trials from various therapeutic areas, and they put emphasis on the use of clinical trial simulations...The authors present a remarkable amount of SAS code examples that could be directly used in daily practice. An extensive overview of modern innovative strategies for clinical trials helps to broaden the horizons of scientists interested in drug or treatment development."" - Iveta Selingerová, ISCB News, July 2020

This is the first edition of a comprehensive book covering the most recent methodology on innovative clinical trial designs for drugs and biological products. It is a great reference book for statisticians, clinicians, and other stakeholders involved in drug discovery and development. ... Chang et al aimed to provide the statistical framework to reach the overall development program optimizations in this book. In addition, innovative methodology to mitigate the risks of failed efficacy, safety, strategy, commercial and operation failures have been described by Chang et al. Special techniques such as clinical trial simulations are highly recommended by the authors. .... In summary, this is an excellent reference book for statisticians, clinicians, and all stakeholders involved in clinical development program with a common goal to reach clinical development optimization. -Holly Huang in the Journal of Biopharmaceutical Statistics, October 2019 The book has a number of detailed examples, and SAS and R code to implement some of the methods described in the text...In summary, this book covers a wide range of interesting topics in clinical trials, and provides an appealing and useful reference to researchers. - Ionut Bebu, JASA 2020 This first edition of this book provides the most recent methodology and statistical considerations in the design and management of clinical trials. It is focused on professionals in drug development, specifically statisticians and clinical researchers...It is, however, a useful insight into strategies for specific situations including personalized medicine, missing data, adaptive design, and multiple testing. The authors include a large number of practical clinical trials from various therapeutic areas, and they put emphasis on the use of clinical trial simulations...The authors present a remarkable amount of SAS code examples that could be directly used in daily practice. An extensive overview of modern innovative strategies for clinical trials helps to broaden the horizons of scientists interested in drug or treatment development. - Iveta Selingerova, ISCB News, July 2020

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Mark Chang, John Balser, Jim Roach, Robin Bliss

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