Clinical Trial Design: Bayesian and Frequentist Adaptive Methods

Description

A balanced treatment of the theories, methodologies, and designissues involved in clinical trials using statisticalmethods There has been enormous interest and development in Bayesianadaptive designs, especially for early phases of clinical trials.However, for phase III trials, frequentist methods still play adominant role through controlling type I and type II errors in thehypothesis testing framework. From practical perspectives, ClinicalTrial Design: Bayesian and Frequentist Adaptive Methods providescomprehensive coverage of both Bayesian and frequentist approachesto all phases of clinical trial design. Before underpinning variousadaptive methods, the book establishes an overview of thefundamentals of clinical trials as well as a comparison of Bayesianand frequentist statistics. Recognizing that clinical trial design is one of the mostimportant and useful skills in the pharmaceutical industry, thisbook provides detailed discussions on a variety of statisticaldesigns, their properties, and operating characteristics for phaseI, II, and III clinical trials as well as an introduction to phaseIV trials. Many practical issues and challenges arising in clinicaltrials are addressed. Additional topics of coverage include: Risk and benefit analysis for toxicity and efficacytrade-offs Bayesian predictive probability trial monitoring Bayesian adaptive randomization Late onset toxicity and response Dose finding in drug combination trials Targeted therapy designs The author utilizes cutting-edge clinical trial designs andstatistical methods that have been employed at the world's leadingmedical centers as well as in the pharmaceutical industry. Thesoftware used throughout the book is freely available on the book'srelated website, equipping readers with the necessary tools fordesigning clinical trials. Clinical Trial Design is an excellent book for courses on thetopic at the graduate level. The book also serves as a valuablereference for statisticians and biostatisticians in thepharmaceutical industry as well as for researchers andpractitioners who design, conduct, and monitor clinical trials intheir everyday work.

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Other editions

• 

  Clinical Trial Design: Bayesian and Frequentist Adaptive Methods

  • 2012-01-03
  • 368 pages
  • Paperback
  • John Wiley & Sons
• 

  Clinical Trial Design

  • 2006
  • 60 pages
  • Paperback
  • Inst of Clinical Research

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