Academic journal article American Journal of Pharmaceutical Education

Tal, J.: Strategy and Statistics in Clinical Trials: A Non-Statistician's Guide to Thinking, Designing, and Executing

Academic journal article American Journal of Pharmaceutical Education

Tal, J.: Strategy and Statistics in Clinical Trials: A Non-Statistician's Guide to Thinking, Designing, and Executing

Article excerpt

TAL, J. Strategy and Statistics in Clinical Trials: A Non-Statistician's Guide to Thinking, Designing, and Executing. Waltham, MA: Academic Press; 2011, 267pp, $69.95 (hardcover), ISBN 9780123869098.

Strategy and Statistics in Clinical Trials: A Non-Statistician's Guide to Thinking, Designing, and Executing is not your typical statistics book. Many academics who see the word "statistics" in a textbook title immediately anticipate seeing mathematical formulas, Greek letters representing key statistical parameters, and sometimes even matrix algebra. You won't find any of those in this book, at least not in the first half; even in the second half, the most complex mathematics you will find is the formula for standard deviation. (p164) Readers should heed the subtitle of the book, "a non-statistician's guide ..." As described in the author's foreword, this book is much more about the theoretical issues surrounding the design of clinical trials and the interpretation of data from those trials. The author's goals and vision for this text are to provide just enough background information (again, to non-statisticians) to allow for more informed and comprehensible dialogue between the many different parties involved with clinical trial design, especially with biostatisticians.

In the book, the author introduces many of the fundamental issues of basic statistical theory, including sampling from a larger population, hypothesis testing, drawing inferences, sensitivity, specificity, paired-testing, and Type I and Type II errors. Interwoven with these concepts are key issues of clinical trials, such as discussion of clinical trial phases and their goals, needs for interim analyses, human subjects and research ethical issues, and theoretical consideration for study endpoints--both single and composite endpoints. Each chapter begins with one or more applied situations taken from actual clinical trials (some may be mildly disguised fictitious drugs). In each case, the author describes the trial design issues and how one of more relevant statistical concepts may be applied to the situation. …

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