Randomised Response-Adaptive Designs in Clinical Trials

Randomised Response-Adaptive Designs in Clinical Trials

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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.show more

Product details

  • Hardback | 339 pages
  • 158 x 236 x 24mm | 699.99g
  • Taylor & Francis Inc
  • Chapman & Hall/CRC
  • United States
  • English
  • 111 black & white illustrations, 30 black & white tables
  • 1584886935
  • 9781584886938

Review quote

"... an excellent textbook on this important topic. In general, the book is well written, easy to navigate, and definitely consistent with the high quality of other books in Monographs on Statistics and Applied Probability series by CRC Press. ... a well-structured and clearly presented textbook on randomized response-adaptive designs. ... Because the book offers a well-balanced mix of practical applications and theoretical results, a wide range of readers, from graduate students to applied statisticians with solid mathematical background, will find the book useful. Readers may find the authors' emphasis on the use of simulation methods to compare methods particularly useful." -The American Statistician, August 2015 "Atkinson and Biswas address [the] questions throughout in a thorough and interesting manner via a logical structure that makes navigating the text a simple and intuitive exercise. ... ideal for anyone looking to learn more about the growing field of response adaptive designs. An easy read, it is well written from the off set, logically advancing the mathematical complexity as the chapters proceed, making it useful for those new to the field of clinical trial design and seasoned trial statisticians alike. Through its use of numerous examples, it clearly achieves its stated aim; to elucidate the practical usefulness of this class of designs. Given their increasing popularity, it may well be one book you should consider adding to your collection sooner rather than later." -ISCB News, 59, June 2015 "This book is clearly written and well-structured for a graduate course as well as consulting statisticians. ... this book is particularly useful for the development of orphan drugs." -Biometrics, March 2015 "... the book covers a very broad range of response-adaptive designs and related issues. ... the book is comprehensively written and gives many exemplary applications from clinical practice. At the same time, the book is mathematically sound and also provides the underlying mathematical formulas and derivations. For these reasons, the book offers important content for applied statisticians but also for more theoretically interested mathematicians." -Biometrical Journal, 2014show more

About Atanu Biswas

Anthony C. Atkinson is an Emeritus Professor of Statistics at the London School of Economics and Political Science. Atanu Biswas is a professor in the Applied Statistics Unit at the Indian Statistical Institute, Kolkata.show more

Table of contents

Introduction: Stories and Data Scope and Limits Two-Treatment Trials with a Binary Response Equal Randomisation Adaptive Allocation Urn Model Some Motivating Clinical Trials Adaptive Design: Controversies and Progress Why Adaptive? How Adaptive? Criticism What Next? Randomised Balanced Sequential Treatment Allocation Introduction Balance with Two Treatments Designs with Three or More Treatments Designs with Covariates The Distribution of Loss and of Bias Heteroscedastic Models More about Biased-Coin Designs Further Reading Response-Adaptive Designs for Binary Responses Introduction Urn Designs Play-the-Winner Rule Randomised Play-the-Winner Rule Generalised Polya Urn Success Driven Design (SDD) Failure-Driven Design (FDD) Birth and Death Urn (BDU) Birth and Death Urn with Immigration Drop-the-Loser Rule Odds Ratio-Based Adaptive Designs Delayed Response in the RPW Rule Prognostic Factors in Urn Designs Targeting an Allocation Proportion Adaptive Designs for Categorical Responses Comparisons and Recommendations Response-Adaptive Designs for Continuous Responses Motivation Some Trials with Continuous Responses Doubly Adaptive Biased-Coin Designs (DBCD) Nonparametric Designs Adaptive Designs for Survival Data Link Function-Based Adaptive Design (BB) Multi-Treatment Multivariate Design DL Rule for Continuous Responses (CDL) Response-Adaptive Designs for Longitudinal Responses Repeated Responses Binary Longitudinal Responses (SLPW) Design and Analysis for the PEMF Data Longitudinal Categorical Responses Longitudinal Multivariate Ordinal Responses Models with Covariates Continuous Longitudinal Responses Random Number of Responses Numerical Illustrations Optimum Biased-Coin Designs with Covariates Modelling and Design Biased-Coin DA-Optimum Designs Numerical Comparisons for Two Treatments Designs for Three Treatments Distribution of Loss Skewed Allocations Skewed Allocation - Numerical Heteroscedastic Normal Models Allocation Rules for Heteroscedastic Models Generalized Linear Models Binary Data Allocation Rules for Binomial Models Gamma Data Loss, Power, Variability Further Reading: Skewed Designs Optimum Response-Adaptive Designs with Covariates Introduction Link-Function-Based Adaptive Design Adaptive Designs Maximising Utility Power Comparisons for Four Rules Redesigning a Trial: Fluoxetine Hydrochloride Extensions Further Reading Optimal Response-Adaptive Designs with Constraints Optimal Designs Subject to Constraints Design of Jennison and Turnbull RSIHR Design Maximising Power: Neyman Allocation Other Designs BM Design ZR Design A General Framework: BBZ Design Two Normal Populations with Unknown Variances Two-Sample Nonparametric Design BM Design for More Than Two Treatments Optimal Designs with More than One Constraint Designs for Survival Times Covariates Implementation Adaptive Constraints Back to Chapter 7 Adaptive Design: Further Important Issues Bayesian Adaptive Designs Two-Stage Adaptive Design Group Sequential Adaptive Design Optimal Design for Binary Longitudinal Responses Inverse Sampling Robustness in Adaptive Designs Missing Data in Response-Adaptive Designs Asymptotic Results for CARA Designs How to Bridge Theory and Practice Appendix: Optimum Design Bibliography Indexshow more