Binary Data Analysis of Randomized Clinical Trials with Noncompliance by Kung-Jong Lui
(Statistics in Practice)

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It is quite common in a randomized clinical trial (RCT) to encounter patients who do not comply with their assigned treatment. Since noncompliance often occurs non-randomly, the commonly-used approaches, including both the as-treated (AT) and as-protocol (AP) analysis, and the intent-to-treat (ITT) (or as-randomized) analysis, are all well known to possibly produce a biased inference of the treatment efficacy.

This book provides a systematic and organized approach to analyzing data for RCTs with noncompliance under the most frequently-encountered situations. These include parallel sampling, stratified sampling, cluster sampling, parallel sampling with subsequent missing outcomes, and a series of dependent Bernoulli sampling for repeated measurements. The author provides a comprehensive approach by using contingency tables to illustrate the latent probability structure of observed data. Using real-life examples, computer-simulated data and exercises in each chapter, the book illustrates the underlying theory in an accessible, and easy to understand way.

Key features:Consort-flow diagrams and numerical examples are used to illustrate the bias of commonly used approaches, such as, AT analysis, AP analysis and ITT analysis for a RCT with noncompliance.Real-life examples are used throughout the book to explain the practical usefulness of test procedures and estimators.Each chapter is self-contained, allowing the book to be used as a reference source.Includes SAS programs which can be easily modified in calculating the required sample size.

Biostatisticians, clinicians, researchers and data analysts working in pharmaceutical industries will benefit from this book. This text can also be used as supplemental material for a course focusing on clinical statistics or experimental trials in epidemiology, psychology and sociology.


About Kung-Jong Lui

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KUNG-JONG LUI is a professor in the Department of Mathematics and Statistics at San Diego State University. Since he obtained his Ph.D. in biostatistics from UCLA in 1982, he has published more than 100 papers in peer-reviewed journals, including "Biometrics, Statistics in Medicine, Biometrical Journal, Psychometrika, Communications in Statistics: Theory and Methods, Science, Proceedings of National Academy of Sciences, Controlled Clinical Trials, Journal of Official Statistics, IEEE Transactions on Reliability, Environmetrics, Test, Computational Statistics and Data Analysis, American Journal of Epidemiology, American Journal of Public Health," etc. He is a Fellow of the American Statistical Association, a life member of the International Chinese Statistical Association, and a member of the Western North American Region of the International Biometric Society.
Published March 31, 2011 by Wiley. 330 pages
Genres: Health, Fitness & Dieting, Professional & Technical, Science & Math. Non-fiction

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