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This book explains how the formulas and procedures for sample size calculations can be used in a variety of clinical research and development stages. It presents real-world examples from several therapeutic areas to illustrate clinical and statistical concepts, interpretations, and interactions. The book also explores emerging topics in pharmaceutical research and development, including QT/QTc studies with time-dependent replicates and the use of propensity score analysis in nonrandomized or observational studies. This edition now provides sample size calculations for three major areas of clinical research: dose response studies, microarray studies, and Bayesian approaches.
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...The second edition has been carefully updated from the first edition. ... One of the strengths of the book is the organizational structure. Each chapter contains comprehensive references, examples, and practical considerations. The book is clearly laid out and easy to read. The table of contents and the index are comprehensive, which makes the book quite useful as a reference. ... In summary, this is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae will aid any researcher designing a study.
—Biometrics, December 2008
This impressive book contains formulae for computing sample size in a wide range of settings. One-sample studies and two-sample comparisons for quantitative, binary, and time-to-event outcomes are covered comprehensively, with separate sample size formulae for testing equality, non-inferiority, and equivalence. Many less familiar topics are also covered, including sample size for comparing k samples, bioequivalence, dose–response studies, and (new in this second edition) microarray studies and Bayesian sample size determination. ... Overall, this is a useful reference for the mathematical statistician ...
—Ian White (Medical Research Council Biostatistics Unit), Journal of the Royal Statistical Society
... The book is well written and easy to read. ... a useful comprehensive reference of sample size calculation procedures for clinical research. It should be a valuable reference book for biostatisticians and clinical scientists in medical or pharmaceutical research.
—Statistics in Medicine, 2008
This book gives excellent coverage to the many types of study design and aims that are likely to be encountered. The main strength of the book is the vast collection of sample size calculations from many different areas of clinical research ... an excellent reference for people involved in the designing of clinical research projects.
—The Journal of Perioperative Practice, September 2008
...This text provides procedures and formulae for the determination of sample size and the appropriate calculation of power for the hypotheses that reflect study objectives under a valid study design. ... this second edition will appeal to both practitioners and students alike.
—International Statistical Review, 2008
Praise for the First Edition
This well-composed book ... contains sample size formulas and examples. ... a good reference book for researchers in clinical trials.
—Journal of Statistical Computation and Simulation, Vol. 74, No. 5, May 2004
The reference list contains details of an excellent collection of articles. The examples are clearly illustrated. This is a fascinating book, and applied statisticians and health and medical researchers will like it a lot. Statistical consultants will be fond of the book as a reference guide.
—Journal of Statistical Computation and Simulation, Vol. 75, No. 9, September 2005
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