Sunday, January 26, 2014

Bayesian Adaptive Methods for Clinical Trials


Bayesian Adaptive Methods for Clinical Trials [Print Replica] [Kindle Edition]

Author: | Language: English | ISBN: B0099VTH96 | Format: PDF, EPUB

Bayesian Adaptive Methods for Clinical Trials
Direct download links available Bayesian Adaptive Methods for Clinical Trials for everyone book 4shared, mediafire, hotfile, and mirror link 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. Scott Berry talks about the book on the CRC Press YouTube Channel . Download latest books on mediafire and other links compilation Bayesian Adaptive Methods for Clinical Trials [Print Replica] [Kindle Edition]
  • File Size: 5862 KB
  • Print Length: 323 pages
  • Publisher: CRC Press; 1 edition (August 22, 2012)
  • Sold by: Amazon Digital Services, Inc.
  • Language: English
  • ASIN: B0099VTH96
  • Text-to-Speech: Not enabled
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  • Lending: Not Enabled
  • Amazon Best Sellers Rank: #1,216,146 Paid in Kindle Store (See Top 100 Paid in Kindle Store)
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.

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