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Modern Adaptive Randomized Clinical Trials: Statistical and Practical Aspects [Kõva köide]

Edited by (EMD Serono, Inc., Billerica, Massachusetts, USA)
  • Formaat: Hardback, 536 pages, kõrgus x laius: 234x156 mm, kaal: 907 g, 52 Tables, black and white; 45 Illustrations, black and white
  • Sari: Chapman & Hall/CRC Biostatistics Series
  • Ilmumisaeg: 30-Jun-2015
  • Kirjastus: Chapman & Hall/CRC
  • ISBN-10: 1482239884
  • ISBN-13: 9781482239881
Teised raamatud teemal:
  • Formaat: Hardback, 536 pages, kõrgus x laius: 234x156 mm, kaal: 907 g, 52 Tables, black and white; 45 Illustrations, black and white
  • Sari: Chapman & Hall/CRC Biostatistics Series
  • Ilmumisaeg: 30-Jun-2015
  • Kirjastus: Chapman & Hall/CRC
  • ISBN-10: 1482239884
  • ISBN-13: 9781482239881
Teised raamatud teemal:
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 Aspectscovers 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.

Arvustused

"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 books 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 "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 books 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

Preface xi
Contributors xv
I Introduction
1(44)
1 An Overview of Adaptive Randomization Designs in Clinical Trials
3(42)
Oleksandr Sverdlov
II Restricted Randomization
45(70)
2 Efron's Biased Coin Design Revisited: Statistical Properties, Randomization-Based Inference and Sequential Monitoring
47(8)
Victoria Plamadeala
3 Adaptive Biased Coins: Achieving Better Balance without Compromising Randomness
55(28)
Alessandro Baldi Antognini
Maroussa Zagoraiou
4 Brick Tunnel and Wide Brick Tunnel Randomization for Studies with Unequal Allocation
83(32)
Olga M. Kuznetsova
Yevgen Tymofyeyev
III Covariate---Adaptive Randomization
115(84)
5 Development of Novel Covariate--Adaptive Randomization Designs
117(14)
Wenle Zhao
6 Optimal Model-Based Covariate--Adaptive Randomization Designs
131(24)
Anthony Atkinson
7 Statistical Inference Following Covariate--Adaptive Randomization: Recent Advances
155(16)
D. Stephen Coad
8 Covariate--Adaptive Randomization with Unequal Allocation
171(28)
Olga M. Kuznetsova
Yevgen Tymofyeyev
IV Response---Adaptive Randomization
199(108)
9 Optimal Allocation Designs for a Multi-Arm Multi-Objective Clinical Trial
201(20)
David Azriel
10 Response---Adaptive Randomization: An Overview of Designs and Asymptotic Theory
221(30)
Li-Xin Zhang
11 Statistical Inference Following Response--Adaptive Randomization
251(18)
Yanqing Yi
Xikui Wang
12 Sample Size Re-Estimation in Adaptively Randomized Clinical Trials with Missing Data
269(18)
Ruitao Lin
Guosheng Yin
13 Some Caveats for Outcome Adaptive Randomization in Clinical Trials
287(20)
Peter F. Thall
Patricia S. Fox
J. Kyle Wathen
V Covariate-Adjusted Response--Adaptive Randomization
307(80)
14 Efficient and Ethical Adaptive Clinical Trial Designs to Detect Treatment--Covariate Interaction
309(18)
Seung Won Hyun
Tao Huang
Hongjian Zhv
15 Longitudinal Covariate-Adjusted Response-Adaptive Randomization: Impact of Missing Data
327(18)
Tao Huang
Hongjian Zhu
16 Targeted Covariate-Adjusted Response--Adaptive LASSO-Based Randomized Controlled Trials
345(26)
Antoine Chambaz
Mark J. van der Laan
Wenjing Zheng
17 Covariate-Balanced Bayesian Adaptive Randomization: Achieving Tradeoff between Inferential and Ethical Goals in Small and Moderate Size Trials
371(16)
Ying Yuan
Jing Ning
VI Randomized Designs with Treatment Selection
387(64)
18 Multi-Arm Multi-Stage Designs for Clinical Trials with Treatment Selection
389(22)
James Wason
19 Sequential Elimination in Multi-Arm Selection Trials
411(16)
Christina Yap
Xuejing Lin
Ying Kuen K. Cheung
20 Accounting for Parameter Uncertainty in Two-Stage Designs for Phase II Dose--Response Studies
427(24)
Emma McCallum
Bjorn Bornkamp
VII Application and Practical Aspects
451
21 A Single Pivotal Adaptive Trial in Infants with Proliferating Hemangioma: Rationale, Design Challenges, Experience and Recommendations
453(30)
Stephane Heritier
Caroline C. Morgan-Bouniol
Serigne N. Lo
Stephanie Gautier
Jean Jacques Voisard
22 Practical Implementation of Dose--Response Adaptive Trials
483(22)
Tom Parke
Martin Kimber
23 Statistical Monitoring of Data in Response--Adaptive Randomized Clinical Trials
505
Paul Gallo
Oleksandr Sverdlov