Sample Sizes for Clinical Trials

About the Book

Drawing on various real-world applications, Sample Sizes for Clinical Trials takes readers through the process of calculating sample sizes for many types of clinical trials. It provides descriptions of the calculations with a practical emphasis. Focusing on normal, binary, ordinal, and survival data, the book explores a range of trials, including superiority, equivalence, non-inferiority, bioequivalence, and precision for both parallel group and crossover designs. The author discusses how trial objectives impact the study design with respect to the derivation of formulae for sample size calculations. He uses real-life studies throughout to show how the concepts and calculations can be employed. This work underscores the importance of sample size calculation in the design of a clinical trial. With useful calculation tables throughout, it enables readers to quickly find an appropriate formula, formula application, and associated worked example.

Table of Contents:

Introduction. Seven Key Steps to Cook up a Sample Size. Sample Sizes for Parallel Group Superiority Trials with Normal Data. Sample Size Calculations for Superiority Crossover Trials with Normal Data. Sample Size Calculations for Equivalence Clinical Trials with Normal Data. Sample Size Calculations for Non-Inferiority Clinical Trials with Normal Data. Sample Size Calculations for Bioequivalence Trials. Sample Size Calculations for Precision-Based Clinical Trials with Normal Data. Sample Size Calculations for Parallel Group Superiority Clinical Trials with Binary Data. Sample Size Calculations for Superiority Crossover Clinical Trials with Binary Data. Sample Size Calculations for Non-Inferiority Trials with Binary Data. Sample Size Calculations for Equivalence Trials with Binary Data. Sample Size Calculations for Precision-Based Trials with Binary Data. Sample Size Calculations for Clinical Trials with Ordinal Data. Sample Size Calculations for Clinical Trials with Survival Data. References. Appendix.

About the Author :

Steven A. Julious is a Senior Lecturer in Medical Statistics at the University of Sheffield. His research interests include clinical trials, clinical trial design, early phase trials, and the development of new methodologies related to clinical trials.

Review :
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, Florida State University 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