- Shopping Bag ( 0 items )
Doody's Review ServiceReviewer: Michael R Jacobs, BS, PharmD (Temple University School of Pharmacy)
Description: This book covers the essential components of statistics and research design related to new drug development.
Purpose: It is intended to serve as an introductory text for students of pharmacy and other health-related disciplines as well as students who might be interested in clinical research and the drug development process. It fills the gap that exists between books that focus on research design and those that address statistical methods. The authors have clearly met this worthy objective.
Audience: Although written for students in the health sciences, the book may also be of value to residents and practitioners who have little experience in clinical research and would like to acquire a basic understanding of this material. Both authors have credentials in clinical research and education.
Features: The book covers the essential topics in study design and statistical analysis as they relate to the drug development process. It uses the unique approach of interweaving research methodology with relevant statistical applications. The chapters follow a logical progression from a short discussion of statistical terminology, through the development of a research hypothesis, to the demonstration of drug efficacy and safety. Illustrations are used when appropriate to deliver a point. Some of the chapters have exercises that can be used for practice problems. Excluding the appendixes, the book is under 200 pages; consequently, although it meets the objective of providing an introduction, some topics may not be covered to the depth some readers desire.
Assessment: The book fills a unique position and uses an innovative method. Although not stated by the authors, it is quite possible that additional users of the book will be the statisticians and researchers who are asked to teach an introductory course in clinical research. The research process is now so sophisticated that some find it difficult to simplify. This book addresses this need.