Strategy and Statistics in Clinical Trials: A Non-Statisticians Guide to Thinking, Designing and Executing

Strategy and Statistics in Clinical Trials deals with the research processes and the role of statistics in these processes. The book offers real-life case studies and provides a practical, how to guide to biomedical R&D. It describes the statistical building blocks and concepts of clinical trials and promotes effective cooperation between statisticians and important other parties.

The discussion is organized around 15 chapters. After providing an overview of clinical development and statistics, the book explores questions when planning clinical trials, along with the attributes of medical products. It then explains how to set research objectives and goes on to consider statistical thinking, estimation, testing procedures, and statistical significance, explanation and prediction. The rest of the book focuses on exploratory and confirmatory clinical trials; hypothesis testing and multiplicity; elements of clinical trial design; choosing trial endpoints; and determination of sample size.

This book is for all individuals engaged in clinical research who are interested in a better understanding of statistics, including professional clinical researchers, professors, physicians, and researchers in laboratory. It will also be of interest to corporate and government laboratories, clinical research nurses, members of the allied health professions, and post-doctoral and graduate students.

• Enables non-statisticians to better understand research processes and statistics' role in these processes
• Offers real-life case studies and provides a practical, "how to" guide to biomedical R&D
• Delineates the statistical building blocks and concepts of clinical trials
• Promotes effective cooperation between statisticians and important other parties

Biomedical R&D can be strikingly complex. Through the persistent efforts of talented individuals from numerous fields we have a steady stream of medical innovation. Such fields include chemistry and clinical medicine, physics and pharmacokinetics, marketing, biology, toxicology, nursing, regulatory and finance. Statistical methods and concepts provide the means for processing the results which are intrinsic for clinical innovations.

Statistics gives life science the language to communicate its achievements and failures. Strategy and Statistics in Clinical Trials provides the tools for formulating judicious questions, designing optimal studies and testing succinct hypotheses.

Written in an accessible style with occasional humor, Strategy and Statistics makes for engaging reading and insightful discussion. The author presents the statistical view of clinical trials and provides a practical guide that contains extensive clinical case studies based on more than 20 years experience.

As biomedical research grows ever more complex, professionals need to understand their colleague’s work in order to communicate productively and move to the next step in the research process. Strategy and Statistics will provide the reader with the tools and framework to maximize efforts and reach objectives in this important process to achieve significant results.

• Enables non-statisticians to better understand research processes and statistics' role in these processes

• Offers real life case studies and provides a practical, "how to" guide to biomedical R & D

• Delineates the statistical building blocks and concepts of clinical trials

• Promotes effective cooperation between statisticians and important other parties