Fundamentals of Clinical Trials

by Lawrence M. Friedman, Curt D. Furberg, David L. DeMets

This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise. A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded. Many contemporary clinical trial examples have been added. There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing and international trials. This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients. The authors use numerous examples of published clinical trials to illustrate the fundamentals. The text is organized sequentially from defining the question to trial closeout. One chapter is devoted to each of the critical areas to aid the clinical trial researcher. These areas include pre-specifying the scientific questions to be tested and appropriate outcome measures, determining the organizational structure, estimating an adequate sample size, specifying the randomization procedure, implementing the intervention and visit schedules for participant evaluation, establishing an interim data and safety monitoring plan, detailing the final analysis plan and reporting the trial results according to the pre-specified objectives. Although a basic introductory statistics course is helpful in maximizing the benefit of this book, a researcher or practitioner with limited statistical background would still find most if not all the chapters understandable and helpful. While the technical material has been kept to a minimum, the statistician may still find the principles and fundamentals presented in this text useful.

Genres: Textbooks, Medicine, Health Care, Psychology, Reference

571 pages, Hardcover

First published November 30, 1981

About the author

Professor of law.

Also author of mystery novels, The Frank May Chronicles.

Reviews

[Scott Pearson]

In the past century, clinical research has grown dramatically as the number of questions about healthcare has increased. The current paradigm of evidence-based medicine describes the practice of prescribing medicines based on their tested strength instead of an individual’s limited experience. Of course, to make such judgments, a rich bed of research evidence needs to exist, and this book succinctly describes how such questions are investigated for eventual dissemination.

This book’s language is succinct and clearly intended for time-strapped researchers & physicians. It does not expand on or illustrate many of the concepts but presumes a high level of clinical knowledge among its readers. The audiobook version, which I listened to, is also abridged and does not contain contents of the full edition.

That said, it offers a comprehensive introduction to the topic. Indeed, I wonder whether re-listening to it might provide me with some benefits because I’m sure I missed a lot in its dense presentation. Even considered are newer topics like research designs besides a randomized clinical trial (the gold standard). The audiobook format provides a proper way to listen to-and-from work or during meal breaks.

[Mary Jean]

Good first book on understanding clinical trial vocabulary, background, planning, and regulatory requirements. Will keep as reference.

[Monika]

PQHS 450

[Mike]

A must-have for anyone just starting out in clinical trials. Clearly written and full of references for further exploration.

[Zhifei Ge]

A well structured introduction to clinical trials. Something to improve is better examples of explaining key concepts.