Fundamental Concepts for New Clinical Trialists: 1st Edition (Hardback) book cover

Fundamental Concepts for New Clinical Trialists

1st Edition

By Scott Evans, Naitee Ting

Chapman and Hall/CRC

348 pages | 38 B/W Illus.

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pub: 2015-09-25
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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


Clinical Trials



The Protocol

Clinical Trial Registration

Ethical Issues

Product Development Process

The Drug Label

Nonclinical Development

Clinical Development

Regulatory Review Organizations

Food and Drug Administration

European Medicines Agency


Clinical Trial Statisticians

Roles of the Clinical Trial Statistician

Important Attributes and Suggestions for Development

Scientific and Practical Issues

General Considerations in Clinical Trial Design

General Design Issues in Clinical Trials

Design Issues in Controlled Clinical Trials

Special Issues

Clinical Trial Designs

Phase I

Other Trial Designs Including Phase II and III

Phase IV

Interim Data Monitoring

Data Monitoring Committees/Data Safety Monitoring Boards

Interim Monitoring Methods

Limitations and Extensions

A Centralized Risk-Based Approach to Monitoring

Analysis Considerations


Other Preparations for Analyses

General Issues

Report Writing

Analysis of Safety, Benefit:Risk, and Quality of Life


Benefit:Risk Evaluation

Quality of Life

Publishing Trial Results

Guidelines for Reporting Clinical Trial Results

Reporting the Results of Subgroup Analyses

Reporting Benefits and Risks

Reporting NI Trials

Reporting Adaptive Designs

Reporting Bayesian Designs

Appendix: Excerpts from the Lipitor® Drug Label


References appear at the end of each chapter.

About the Authors/Editors

Dr. Scott Evans teaches clinical trials at Harvard University, where he is the director of the Statistical and Data Management Center for the Antibacterial Resistance Leadership Group, an NIH-funded clinical trials network. He serves on a U.S. FDA Advisory Committee and several data monitoring committees for industry and NIH-sponsored clinical trials. He has been a recipient of the Mosteller Statistician of the Year Award and is a fellow of the American Statistical Association. Dr. Evans is a visiting professor at the Department of Medical Statistics at Osaka University and serves as the executive editor for CHANCE and the editor-in-chief of Statistical Communications in Infectious Diseases.

Dr. Naitee Ting has close to 30 years of experience in the pharmaceutical industry and currently works at Boehringer Ingelheim. He has also taught courses on clinical trials in the Department of Statistics at the University of Connecticut, University of Rhode Island, and Department of Biostatistics at Columbia University. He is a fellow of the American Statistical Association.

About the Series

Chapman & Hall/CRC Biostatistics Series

Learn more…

Subject Categories

BISAC Subject Codes/Headings:
MATHEMATICS / Probability & Statistics / General
MEDICAL / Pharmacology