Clinical Trial Design

Bayesian and Frequentist Adaptive Methods

Guosheng Yin

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English

John Wiley & Sons Inc
19 December 2011

Clinical trials

A balanced treatment of the theories, methodologies, and design issues involved in clinical trials using statistical methods

There has been enormous interest and development in Bayesian adaptive designs, especially for early phases of clinical trials. However, for phase III trials, frequentist methods still play a dominant role through controlling type I and type II errors in the hypothesis testing framework. From practical perspectives, Clinical Trial Design: Bayesian and Frequentist Adaptive Methods provides comprehensive coverage of both Bayesian and frequentist approaches to all phases of clinical trial design. Before underpinning various adaptive methods, the book establishes an overview of the fundamentals of clinical trials as well as a comparison of Bayesian and frequentist statistics.

Recognizing that clinical trial design is one of the most important and useful skills in the pharmaceutical industry, this book provides detailed discussions on a variety of statistical designs, their properties, and operating characteristics for phase I, II, and III clinical trials as well as an introduction to phase IV trials. Many practical issues and challenges arising in clinical trials are addressed. Additional topics of coverage include:

Risk and benefit analysis for toxicity and efficacy trade-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 and statistical methods that have been employed at the world's leading medical centers as well as in the pharmaceutical industry. The software used throughout the book is freely available on the book's related website, equipping readers with the necessary tools for designing clinical trials.

Clinical Trial Design is an excellent book for courses on the topic at the graduate level. The book also serves as a valuable reference for statisticians and biostatisticians in the pharmaceutical industry as well as for researchers and practitioners who design, conduct, and monitor clinical trials in their everyday work.

By: Guosheng Yin
Imprint: John Wiley & Sons Inc
Country of Publication: United States
Dimensions: Height: 244mm, Width: 163mm, Spine: 24mm
Weight: 644g
ISBN: 9780470581711
ISBN 10: 0470581719
Pages: 368
Publication Date: 19 December 2011
Audience: Professional and scholarly , Undergraduate
Format: Hardback
Publisher's Status: Active

GUOSHENG YIN, PhD, is Associate Professor in the Department of Statistics and Actuarial Science at The University of Hong Kong, and Adjunct Associate Professor in the Department of Biostatistics at The University of Texas MD Anderson Cancer Center.

Reviews for Clinical Trial Design: Bayesian and Frequentist Adaptive Methods

<p> In summary, this book is useful for anyone interested indesign and analysis of clinical studies. The main strengths of thisbook are the well-balanced approach between statistical theoriesand statistical analysis methods of the design issues involved inclinical trials. I would suggest the usage of this book as aMaster s level course in biostatistics. (Journal of Biopharmaceutical Statistics, 1 May 2013) <p> The author should be commended; the text is well writtenand packed with information that belies the book s trimsize. (Drug Information Journal, 30 October 2012) <p> The book accompanied with software developed at MDAnderson Cancer Center provides an excellent reference for everyonewho works in clinical trial field. (Biometrics,1 July 2012)