Description: The second of a two-volume set on Methods and Applications of Statistics in Clinical Trials, this book focuses on planning, analysis, and inferential methods. Volume 1 covered principles, trials, and designs. This is the seventh entry in the Methods and Applications of Statistics series, edited by N. Balakrishnan, a well-known figure in the field of statistics.
Purpose: The purpose is to provide a detailed discourse on the history, development, and modern advances in planning, analysis, and inferential methods of clinical trials.
Audience: A variety of audiences are served by the book, including those who are interested in understanding the mathematics and concepts behind statistical tests and those who are interested in the planning and execution of a specific type of clinical trial.
Features: The 57 chapters describe a wide variety of subjects including methods of statistical analysis of clinical trials, meta-analysis, data properties and processing, modeling, bias, screening, statistical principles of imaging and micro-arrays, and outcome presentation methods. The overall scope is quite comprehensive. The book is based on the Wiley Encyclopedia of Clinical Trials, but has more updated information. The chapters are arranged alphabetically and hence not organized by content. Chapters are written by different authors, and therefore they do not conform to a uniform structure. However, the book is still arranged in an easy to read fashion. Some chapters have examples where needed and the book is adequately illustrated for concepts, particularly in imaging sciences. The fascinating historical tidbits in the book and the up-to-date modern concepts and methods go hand in hand. Occasionally, the book provides the mathematical background for those interested in understanding the derivations and the theorems that form the backbone of each statistical method. A basic understanding of statistics and calculus is therefore necessary to fully comprehend some material. At the end of each chapter there are multiple references as well as further sources for more information, which is helpful. There are no computational algorithms or codes for statistical software, though some chapters do mention the necessary PROCs for SAS for certain statistical methods. One chapter is also devoted to the statistical methods and results of the women's health initiative.
Assessment: This is a comprehensive book on planning, analysis, and inferential methods in clinical trials and complements the rest of the series.