Sample Sizes for Clinical Trials (second edition)

Steven Julious is an established researcher who has made substantial contributions to clinical trial methodology, particularly in the area of sample size determination across a broad range of experimental settings. Knowing the author and his numerous contributions to this topic, we gladly took the opportunity to read the second edition of his book, which, since the publication of its first edition in 2009, has become a standard reference in this field. Sample size calculation is a task that every researcher engaged in clinical trials will encounter sooner or later. As with the first edition, these researchers are the primary audience of the second edition as well. The book provides a comprehensive coverage of sample size methodology for normal, binary, ordinal, and survival outcome data in superiority, equivalence, non-inferiority, and bioequivalence settings, for both parallel-group and crossover designs. The material is organized thematically into 22 chapters of varying length. Compared with the first edition, this second edition has been substantially updated. Several entirely new chapters have been added—such as those on multiplicity, cluster-randomized trials, pilot studies, and single-arm trials—while many existing chapters have been thoroughly revised. For a book of this nature, the inclusion of numerous formulas is inevitable; however, these are complemented by worked examples based on real-world scenarios and by comprehensive reference tables. The theoretical background and derivation of basic sample size formulas are clearly explained, and references to the original literature are provided for more complex methods, such as those for the analysis of ordinal data. Throughout the book, the author highlights how trial objectives affect study design and the corresponding sample size requirements.