Sample Sizes for Clinical Trials - Hardcover

Julious, Steven A.

9781584887393: Sample Sizes for Clinical Trials

Hardcover

ISBN 10: 1584887397 ISBN 13: 9781584887393

Publisher: Chapman and Hall/CRC, 2009

Featuring worked examples and problems based on real-world scenarios, this book takes readers through the process of calculating the sample size for various types of clinical trials. It covers the most common types of clinical trials across different phases. It discusses how assumptions made in a sample size calculation can impact the calculation.

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Review:

"... a useful compendium that takes the reader through the process of calculating sample sizes and addresses many points to consider for the most common types of clinical trials and data. ... this book provides a good introduction to the most common trial design scenarios for comparing two treatments. With a lot of hints, tips, and numeric examples, it is easy to read for statisticians and non-statisticians."
―ISCB News, December 2015

"... it is lively, peppered with opinions and advice, and full of methods. ... the book has many useful formulas for a variety of designs. It is well organized, so users can easily find the section relevant to their needs. And the plethora of worked examples is very helpful. ... a useful introduction to the clinical researcher and as a reference for the statistician interested in sample size formulae for specific designs."
―Janet T. Wittes, Biometrics, February 2012

"The book’s author is an expert and experienced researcher of clinical trial design and conduct. ... True to its purpose as a reference book (or manual) for sample size calculation, the book covers all relevant formulas for sample size calculation. It also includes examples to demonstrate the implementation of the formulas, and even has boxed texts to highlight major ideas and "to do lists" for users. The demonstrations of the methods and formulas using study examples are a very helpful feature of the book. For each type of response (including even ordinal and survival responses), formulas for various types of clinical trials, including equivalent trials and design with interim analysis, are covered."
―Debajyoti Sinha, Journal of the American Statistical Association, September 2011, Vol. 106

"The book should be useful as a reference work for statisticians or other researchers that are interested in quickly finding an appropriate formula for a sample size calculation problem. Although the worked examples may be quite short, they are useful for understanding the discussed methods and for the reader to apply the methods by himself or herself. Each chapter also ends with a valuable short summary that gives the key messages to be learned from the chapter in question."
―International Statistical Review, 2010, 78, 3

"... fairly comprehensive in its description of sample size calculations across a multitude of trial designs and analytical approaches. ... It is worth noting that the accumulation of references to the author’s published work in a multitude of journals as one reads through the text is demonstrative of the level of contributions he has made to the topic of this book. He clearly has a comprehensive knowledge of the literature that contributes to the body of knowledge in this area of methodology. ... this is an extremely useful reference book that does not require a large investment of time to be able to put it to good use. The nomenclature used is clear and not overly complex, and key points are highlighted both within the chapter contents as well as in tabular format at the end of each chapter. ... he also covers some less common topics, ... which are very useful in practice and somewhat unique as topics for a text on this subject matter."
―Christopher A. Assaid, Journal of Biopharmaceutical Statistics, Issue 4, 2010

Synopsis:

With an emphasis on trials in a regulatory setting, "Estimating Samples Sizes in Clinical Trials" provides a hands-on, practical introduction to the calculations performed for sample size estimation in clinical trials. This comprehensive book presents key concepts of clinical trials as well as different trial objectives, including bioequivalence and noninferiority. It covers normal, binary, ordinal, survival, and other types of data. Although some mathematical formulas are required, the book focuses on the application of methods to real-world problems, featuring numerous worked examples that are implemented using SAS. Datasets and code are available for download on the web.

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