Response-adaptive Randomization in Neurological Clinical Trials

Response-adaptive Randomization in Neurological Clinical Trials PDF Author: Amy S. Nowacki
Publisher:
ISBN:
Category :
Languages : en
Pages : 338

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Response-adaptive Randomization in Neurological Clinical Trials

Response-adaptive Randomization in Neurological Clinical Trials PDF Author: Amy S. Nowacki
Publisher:
ISBN:
Category :
Languages : en
Pages : 338

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Response Adaptive Randomization in Clinical Trials with Continuous and Survival Time Outcomes

Response Adaptive Randomization in Clinical Trials with Continuous and Survival Time Outcomes PDF Author: Lanju Zhang
Publisher:
ISBN:
Category :
Languages : en
Pages : 244

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The Theory of Response-Adaptive Randomization in Clinical Trials

The Theory of Response-Adaptive Randomization in Clinical Trials PDF Author: Feifang Hu
Publisher: John Wiley & Sons
ISBN: 0470055871
Category : Mathematics
Languages : en
Pages : 234

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Book Description
Presents a firm mathematical basis for the use of response-adaptive randomization procedures in practice The Theory of Response-Adaptive Randomization in Clinical Trials is the result of the authors' ten-year collaboration as well as their collaborations with other researchers in investigating the important questions regarding response-adaptive randomization in a rigorous mathematical framework. Response-adaptive allocation has a long history in biostatistics literature; however, largely due to the disastrous ECMO trial in the early 1980s, there is a general reluctance to use these procedures. This timely book represents a mathematically rigorous subdiscipline of experimental design involving randomization and answers fundamental questions, including: How does response-adaptive randomization affect power? Can standard inferential tests be applied following response-adaptive randomization? What is the effect of delayed response? Which procedure is most appropriate and how can "most appropriate" be quantified? How can heterogeneity of the patient population be incorporated? Can response-adaptive randomization be performed with more than two treatments or with continuous responses? The answers to these questions communicate a thorough understanding of the asymptotic properties of each procedure discussed, including asymptotic normality, consistency, and asymptotic variance of the induced allocation. Topical coverage includes: The relationship between power and response-adaptive randomization The general result for determining asymptotically best procedures Procedures based on urn models Procedures based on sequential estimation Implications for the practice of clinical trials Useful for graduate students in mathematics, statistics, and biostatistics as well as researchers and industrial and academic biostatisticians, this book offers a rigorous treatment of the subject in order to find the optimal procedure to use in practice.

Modern Adaptive Randomized Clinical Trials

Modern Adaptive Randomized Clinical Trials PDF Author: Oleksandr Sverdlov
Publisher: CRC Press
ISBN: 1482239892
Category : Mathematics
Languages : en
Pages : 536

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Book Description
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 random

Randomization in Clinical Trials

Randomization in Clinical Trials PDF Author: William F. Rosenberger
Publisher: John Wiley & Sons
ISBN: 0471654078
Category : Mathematics
Languages : en
Pages : 286

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Book Description
A unique overview that melds the concepts of conditionalprobability and stochastic processes into real-lifeapplications The role of randomization techniques in clinical trials has becomeincreasingly important. This comprehensive guide combines both theapplied aspects of randomization in clinical trials with aprobabilistic treatment of properties of randomization. Taking anunabashedly non-Bayesian and nonparametric approach to inference,the book focuses on the linear rank test under a randomizationmodel, with added discussion on likelihood-based inference as itrelates to sufficiency and ancillarity. Developments in stochasticprocesses and applied probability are also given where appropriate.Intuition is stressed over mathematics, but not without a cleardevelopment of the latter in the context of the former. Providing a consolidated review of the field, the book includesrelevant and practical discussions of: * The benefits of randomization in terms of reduction of bias * Randomization as a basis for inference * Covariate-adaptive and response-adaptive randomization * Current philosophies, controversies, and new developments With ample problem sets, theoretical exercises, and short computersimulations using SAS, Randomization in Clinical Trials: Theory andPractice is equally useful as a standard textbook in biostatisticsgraduate programs as well as a reliable reference forbiostatisticians in practice.

Randomised Response-Adaptive Designs in Clinical Trials

Randomised Response-Adaptive Designs in Clinical Trials PDF Author: Anthony C Atkinson
Publisher: CRC Press
ISBN: 1584886935
Category : Mathematics
Languages : en
Pages : 341

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Book Description
Randomised Response-Adaptive Designs in Clinical Trials presents methods for the randomised allocation of treatments to patients in sequential clinical trials. Emphasizing the practical application of clinical trial designs, the book is designed for medical and applied statisticians, clinicians, and statisticians in training. After introducing clinical trials in drug development, the authors assess a simple adaptive design for binary responses without covariates. They discuss randomisation and covariate balance in normally distributed responses and cover many important response-adaptive designs for binary responses. The book then develops response-adaptive designs for continuous and longitudinal responses, optimum designs with covariates, and response-adaptive designs with covariates. It also covers response-adaptive designs that are derived by optimising an objective function subject to constraints on the variance of estimated parametric functions. The concluding chapter explores future directions in the development of adaptive designs.

Covariate-adjusted Response-adaptive Randomization Procedures in Multi-arm Clinical Trials with Continuous Response Variables

Covariate-adjusted Response-adaptive Randomization Procedures in Multi-arm Clinical Trials with Continuous Response Variables PDF Author: Shu-Xia Li
Publisher:
ISBN:
Category :
Languages : en
Pages : 284

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Response Adaptive Designs for Clinical Trials with Continuous Outcomes

Response Adaptive Designs for Clinical Trials with Continuous Outcomes PDF Author: Yu Zhang
Publisher:
ISBN:
Category :
Languages : en
Pages :

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Response Adaptive Randomization Using Surrogate and Primary Endpoints

Response Adaptive Randomization Using Surrogate and Primary Endpoints PDF Author: Hui Wang
Publisher:
ISBN:
Category :
Languages : en
Pages :

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Book Description
In recent years, adaptive designs in clinical trials have been attractive due to their efficiency and flexibility. Response adaptive randomization procedures in phase II or III clinical trials are proposed to appeal ethical concerns by skewing the probability of patient assignments based on the responses obtained thus far, so that more patients will be assigned to a superior treatment group. General response-adaptive randomizations usually assume that the primary endpoint can be obtained quickly after the treatment. However, in real clinical trials, the primary outcome is delayed, making it unusable for adaptation. Therefore, we utilize surrogate and primary endpoints simultaneously to adaptively assign subjects between treatment groups for clinical trials with continuous responses. We explore two types of primary endpoints commonly used in clinical tirials: normally distributed outcome and time-to-event outcome. We establish a connection between the surrogate and primary endpoints through a Bayesian model, and then update the allocation ratio based on the accumulated data. Through simulation studies, we find that our proposed response adaptive randomization is more effective in assigning patients to better treatments as compared with equal allocation randomization and standard response adaptive randomization which is solely based on the primary endpoint.

Adaptive Design Methods in Clinical Trials

Adaptive Design Methods in Clinical Trials PDF Author: Shein-Chung Chow
Publisher: CRC Press
ISBN: 1439839883
Category : Mathematics
Languages : en
Pages : 368

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Book Description
With new statistical and scientific issues arising in adaptive clinical trial design, including the U.S. FDA's recent draft guidance, a new edition of one of the first books on the topic is needed. Adaptive Design Methods in Clinical Trials, Second Edition reflects recent developments and regulatory positions on the use of adaptive designs in clini