Overview

Is adaptive randomization always better than traditional fixed-schedule randomization? Which procedures should be used and under which circumstances? What special considerations are required for adaptive randomized trials? What kind of statistical inference should be used to achieve valid and unbiased treatment comparisons following adaptive randomization designs? Modern Adaptive Randomized Clinical Trials: Statistical and Practical Aspects answers these questions and more. From novel designs to cutting-edge applications, this book presents several new and key developments in adaptive randomization. It also offers a fresh and critical look at a number of already-classical topics. Featuring contributions from statisticians, clinical trialists, and subject-matter experts in academia and the pharmaceutical industry, the text: Clarifies the taxonomy of the concept of adaptive randomization Discusses restricted, covariate-adaptive, response-adaptive, and covariate-adjusted response-adaptive (CARA) randomization designs, as well as randomized designs with treatment selection Gives an exposition to many novel adaptive randomization techniques such as brick tunnel randomization, targeted least absolute shrinkage and selection operator (LASSO)-based CARA randomization, multi-arm multi-stage (MAMS) designs, to name a few Addresses the issues of statistical inference following covariate-adaptive and response-adaptive randomization designs Describes a successful implementation of a single pivotal phase II/III adaptive trial in infants with proliferating hemangioma Explores some practical aspects of phase II dose-ranging studies and examines statistical monitoring and interim analysis issues in response-adaptive randomized clinical trials Modern Adaptive Randomized Clinical Trials: Statistical and Practical Aspects covers a wide spectrum of topics related to adaptive randomization designs in contemporary clinical trials. The book provides a thorough exploration of the merits of adaptive randomization and aids in identifying when it is appropriate to apply such designs in practice.

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9781482239881

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Reviews

The discussion of the various type of adaptive designs is quite thorough and broad, incorporating many of the recent advances in the field. The book provides an excellent theoretical description of many of the more commonly employed adaptations. ... a valuable resource for researchers and practitioners in adaptive trial design. The book covers a wide range of topics in adaptive randomization, going into depth in a generalized framework that applies to a broad range of trial designs, and also includes some valuable methods on how to put these trials into practice. -Journal of Biopharmaceutical Statistics, Issue 2, 2016

The discussion of the various type of adaptive designs is quite thorough and broad, incorporating many of the recent advances in the field. The book provides an excellent theoretical description of many of the more commonly employed adaptations. ... a valuable resource for researchers and practitioners in adaptive trial design. The book covers a wide range of topics in adaptive randomization, going into depth in a generalized framework that applies to a broad range of trial designs, and also includes some valuable methods on how to put these trials into practice. -Journal of Biopharmaceutical Statistics, Issue 2, 2016 This is an impressive and useful book, which covers various types of adaptive randomisation designs and provides a thorough exploration of the merits of adaptive randomisation. -Lili Zhao, Department of Biostatistics, University of Michigan . . the book meets its objective of providing an up-to-date discussiononadaptive randomization designs and their applications in clinical trials. It is a great resource for those who are new to the field or for those who want an overview of the latest methods. -Stanley E. Lazic, AstraZeneca, Cambridge Overall, the book covers many aspects of adaptive randomization studies and reports many new developments in the field with detailed statistical considerations. As regulatory reviewers, we can see ourselves delving into this book when we receive a submission with an adaptive randomization trial ... The book would also prove a valuable resource for researchers in the field of adaptive randomization. -Xiting Yang and Gerry Gray, Food and Drug Administration

The discussion of the various type of adaptive designs is quite thorough and broad, incorporating many of the recent advances in the field. The book provides an excellent theoretical description of many of the more commonly employed adaptations. ... a valuable resource for researchers and practitioners in adaptive trial design. The book covers a wide range of topics in adaptive randomization, going into depth in a generalized framework that applies to a broad range of trial designs, and also includes some valuable methods on how to put these trials into practice. -Journal of Biopharmaceutical Statistics, Issue 2, 2016 This is an impressive and useful book, which covers various types of adaptive randomisation designs and provides a thorough exploration of the merits of adaptive randomisation. -Lili Zhao, Department of Biostatistics, University of Michigan . . the book meets its objective of providing an up-to-date discussiononadaptive randomization designs and their applications in clinical trials. It is a great resource for those who are new to the field or for those who want an overview of the latest methods. -Stanley E. Lazic, AstraZeneca, Cambridge Overall, the book covers many aspects of adaptive randomization studies and reports many new developments in the field with detailed statistical considerations. As regulatory reviewers, we can see ourselves delving into this book when we receive a submission with an adaptive randomization trial . . . The book would also prove a valuable resource for researchers in the field of adaptive randomization. -Xiting Yang and Gerry Gray, Food and Drug Administration Many authors participated in assembling the book, including worldclass statisticians, each of whom contributed to the completeness of the disclosure of the book's topic. The core value of the book is more than in simply demonstrated theories and formulas, but also in advice given on their practical application, specified examples, references to modern regulatory rules and links to SAS & R codes. It is a really well organised book that will be useful first and foremost for statisticians involved in clinical trials. -International Society for Clinical Biostatistics . . . the book gives a broad overview of the different adaptive randomization strategies. Due to a clear organization and well-written introduction it is convenient to read, gives fascinating insights into different options, but may also raise further questions on applicability, acceptability, and gain in efficiency, stimulating further discussion and research in this area. -Biometrical Journal , 2017

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Oleksandr Sverdlov

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