Short description:

This text describes the core scientific concepts of designing, data monitoring, analyzing, and reporting clinical trials as well as the practical aspects of trials not typically discussed in statistical methodology textbooks. It offers first-hand perspectives on real-world issues, such as common and challenging clinical trial designs and the proper reporting of clinical trial results in the medical literature. Drawing on their experiences in academia and industry, the authors provide a foundation for understanding the fundamental concepts necessary for working in clinical trials.

Long description:

Fundamental Concepts for New Clinical Trialists describes the core scientific concepts of designing, data monitoring, analyzing, and reporting clinical trials as well as the practical aspects of trials not typically discussed in statistical methodology textbooks.

The first section of the book provides background information about clinical trials. It defines and compares clinical trials to other types of research studies and discusses clinical trial phases, registration, the protocol document, ethical issues, product development, and regulatory processes. It also includes a special chapter outlining the valuable attributes that statisticians can develop to maximize their contributions to a clinical trial.

The second section examines scientific issues faced in each progressive step of a clinical trial. It covers issues in trial design, such as randomization, blinding, control-group selection, endpoint selection, superiority versus noninferiority, and parallel group versus crossover designs; data monitoring; analyses of efficacy, safety, and benefit-risk; and the reporting/publication of clinical trial results.

As clinical trials remain the gold standard research studies for evaluating the effects of a medical intervention, newcomers to the field must have a fundamental understanding of the concepts to tackle real-world issues in all stages of trials. Drawing on their experiences in academia and industry, the authors provide a foundation for understanding the fundamental concepts necessary for working in clinical trials.

"The book focuses on important concepts and promotes ?thinking clinical trials?, and it is very readable. This book targets both statisticians and non-statisticians and wishes to facilitate better communication between them. I found that some chapters are especially useful for statisticians involved in clinical trials. . . Dr Evans uses this book as part of his ?Principles of Clinical Trials? course at the Harvard School of Public Health. Overall, it is an exciting book!"
~International Statistical Review

"Statisticians learn the easy part of designing and analyzing clinical trials in class, but we usually learn the hard parts by our post-graduate failures. This book offers a course outline and valuable set of instructions to describe how to avoid many lessons we might otherwise have to learn the hard way."
~The International Biometric Society

Table of Contents:

Background: Clinical Trials. Product Development Process. Regulatory Review Organizations. Clinical Trial Statisticians. Scientific and Practical Issues: General Considerations in Clinical Trial Design. Clinical Trial Designs. Interim Data Monitoring. Analysis Considerations. Analysis of Safety, Benefit:Risk, and Quality of Life. Publishing Trial Results. Appendix. Index.