Modern Adaptive Randomized Clinical Trials

Statistical and Practical Aspects

AvOleksandr Sverdlov

Inbunden, Engelska, 2015

Del i serien Chapman & Hall/CRC Biostatistics Series

2 747 kr

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Beskrivning

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 randomizationDiscusses restricted, covariate-adaptive, response-adaptive, and covariate-adjusted response-adaptive (CARA) randomization designs, as well as randomized designs with treatment selectionGives 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 fewAddresses the issues of statistical inference following covariate-adaptive and response-adaptive randomization designsDescribes a successful implementation of a single pivotal phase II/III adaptive trial in infants with proliferating hemangiomaExplores some practical aspects of phase II dose-ranging studies and examines statistical monitoring and interim analysis issues in response-adaptive randomized clinical trialsModern 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.

Produktinformation

Utgivningsdatum:2015-06-30
Mått:156 x 234 x 35 mm
Vikt:907 g
Format:Inbunden
Språk:Engelska
Serie:Chapman & Hall/CRC Biostatistics Series
Antal sidor:536
Förlag:Taylor & Francis Inc
ISBN:9781482239881

Utforska kategorier

Farmakologi inom Medicin
Medicinsk utrustning och medicinska tekniker inom Medicin
Epidemiologi och medicinsk statistik inom Medicin

Recensioner i media

"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, 2016This is an impressive and useful book, which covers various types of adaptive randomisationdesigns 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

Innehållsförteckning

An Overview of Adaptive Randomization Designs in Clinical Trials. Efron's Biased Coin Design Revisited: Statistical Properties, Randomization-Based Inference, and Sequential Monitoring. Adaptive Biased Coins: Achieving Better Balance without Compromising Randomness. Brick Tunnel and Wide Brick Tunnel Randomization for Studies with Unequal Allocation. Development of Novel Covariate-Adaptive Randomization Designs. Optimal Model-Based Covariate-Adaptive Randomization Designs. Statistical Inference Following Covariate-Adaptive Randomisation: Recent Advances. Covariate-Adaptive Randomization with Unequal Allocation. Optimal Allocation Designs for a Multi-Arm Multi-Objective Clinical Trial. Response-Adaptive Randomization: An Overview of Designs and Asymptotic Theory. Statistical Inference Following Response-Adaptive Randomization. Sample Size Re-Estimation in Adaptively Randomized Clinical Trials with Missing Data. Some Caveats for Outcome Adaptive Randomization in Clinical Trials. Efficient and Ethical Adaptive Clinical Trial Designs to Detect Treatment–Covariate Interaction. Longitudinal Covariate-Adjusted Response-Adaptive Randomization: Impact of Missing Data. Targeted Covariate-Adjusted Response-Adaptive LASSO-Based Randomized Controlled Trials. Covariate-Balanced Bayesian Adaptive Randomization: Achieving Tradeoff Between Inferential and Ethical Goals in Small and Moderate Size Trials. Multi-Arm Multi-Stage Designs for Clinical Trials with Treatment Selection. Sequential Elimination in Multi-Arm Selection Trials. Accounting for Parameter Uncertainty in Two-Stage Designs for Phase II Dose-Response Studies. A Single Pivotal Adaptive Trial in Infants with Proliferating Hemangioma: Rationale, Design Challenges, Experience, and Recommendations. Practical Implementation of Dose–Response Adaptive Trials. Statistical Monitoring of Data in Response-Adaptive Randomized Clinical Trials.