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 processesOffers real-life case studies and provides a practical, "how to" guide to biomedical R&DDelineates the statistical building blocks and concepts of clinical trialsPromotes effective cooperation between statisticians and important other parties

Chapter 1.) Clinical Development and Statistics: The General View

Chapter 2.) Questions when Planning Trials

Chapter 3.) Medical Product Attributes

Chapter 4.) Setting Research Objectives

Chapter 5.) Statistical Thinking

Chapter 6.) Estimation

Chapter 7.) From Description to Testing: A Beginning

Chapter 8.) Statistical Significance, Explanation and Prediction

Chapter 9.) Exploratory and Confirmatory Clinical Trials

Chapter 10.) One, Two, Three Testing: Hypothesis Testing and Multiplicity

Chapter 11.) Elements of Clinical Trial Design I: Putting it together

Chapter 12.) Elements of Clinical Trial Design II

Chapter 13.) Choosing Trial Endpoints

Chapter 14.) Determination of Sample Size

Chapter 15.) Concluding Remarks