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(More customer reviews)In the pharmaceutical industry adaptive designs are currently the rage because of their many potential advantages due to their flexibility. It allows you to stop early for efficacy or futility. It can do drug dose selection more easily and may have patients on inferior treatment for smaller amounts of time. There have already been four or five books published from the frequentist point of view. This is the first serious text on adaptive designs using the Bayesian approach. Pharmaceutical companies including Johnson and Johnson, Eli Lilly, Pfizer, Merck, Novartis, Novo Nordisk, Millennium, AMAG and GlaxoSmithKline have all been successful at running adaptive trials. Merck for example has already completed more than 40 adaptive design trials. Such trials can be done in phase II, phase III or a combining of phases II and III in a single adaptive trial. Merck claims to have completed over 40 adaptive trials. The M D Anderson Medical Center at UT Houston runs hundreds of adaptive trials (all as far as I know using the Bayesian methodology). Don Berry runs the biostatistics group at M D Anderson and he and his son scott own a consulting group that helps companies run Bayesian adaptive designs. Eli Lilly has been one of their clients on a drug trial and Biosense Webster, a J& J company, used them for a Bayesian trial on one of their ablation catheters. Scott Berry isone of the authors of this book and a lot of the book is devoted to work of Berry first at Duke and then later at M D Anderson and Berry Consultants.
Adaptive designs have logistic problems but companies have been able to overcome the problems motivated by the overall time and money saving benefits. All types of studies are illustrated from phase I through phase III and the examples are real and practical. Even when taking the Bayesian approach issues of frequentist properties for the designs comes up. Missing data, multiple testing, type I error and power of the test conditional and unconidtional are important when the frequentist approach is applied. The authors admit that both frequentist and Bayesian properties for a design are important and can be evaluated through simulation.
Although adaptive designs can be implemented effectively using either the Bayesian or the frequentist approaches. But Bayesian trials are a little more natural and simpler. This is the right book to get if you are interested in Bayesian methods.
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Bayesian Adaptive Methods for Clinical Trials (Chapman & Hall/CRC Biostatistics Series)Already popular in the analysis of medical device trials, adaptive Bayesian designs are increasingly being used in drug development for a wide variety of diseases and conditions, from Alzheimer's disease and multiple sclerosis to obesity, diabetes, hepatitis C, and HIV. Written by leading pioneers of Bayesian clinical trial designs, Bayesian Adaptive Methods for Clinical Trials explores the growing role of Bayesian thinking in the rapidly changing world of clinical trial analysis.The book first summarizes the current state of clinical trial design and analysis and introduces the main ideas and potential benefits of a Bayesian alternative. It then gives an overview of basic Bayesian methodological and computational tools needed for Bayesian clinical trials. With a focus on Bayesian designs that achieve good power and Type I error, the next chapters present Bayesian tools useful in early (Phase I) and middle (Phase II) clinical trials as well as two recent Bayesian adaptive Phase II studies: the BATTLE and ISPY-2 trials. In the following chapter on late (Phase III) studies, the authors emphasize modern adaptive methods and seamless Phase II-III trials for maximizing information usage and minimizing trial duration. They also describe a case study of a recently approved medical device to treat atrial fibrillation. The concluding chapter covers key special topics, such as the proper use of historical data, equivalence studies, and subgroup analysis.For readers involved in clinical trials research, this book significantly updates and expands their statistical toolkits. The authors provide many detailed examples drawing on real data sets. The R and WinBUGS codes used throughout are available on supporting websites.
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