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.
With complete coverage of issues in all phases of clinical trials, including design, data monitoring, analyses, interpretation, and reporting, this book provides an overview of fundamental concepts important to statisticians working with clinical trials. It examines issues related to product development and regulation, and then discusses the attributes that statisticians can acquire to maximize their contribution to the research. The co-authors draw on their experience in industry and academia to provide balanced, practical guidance on how statisticians can apply their knowledge to address real world clinical trial issues.
"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
