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Overview
At last – a new edition of the highly acclaimed book Clinical Trials in Psychiatry
This book provides a concise but thorough overview of clinical trials in psychiatry, invaluable to those seeking solutions to numerous problems relating to design, methodology and analysis of such trials. Practical examples and applications are used to ground theory whenever possible. The Second Edition includes new information regarding:
- Recent important psychiatric trials
- More specific discussion of psychiatry in the USA and the particular problems of trials in the USA, including comments about the FDA (U.S. Food and Drug Administration)
- An extended chapter on meta-analysis
- Further discussion of sub-group analysis
Special features include appendices outlining how to design and report clinical trials, what websites and software programs are appropriate and an extensive reference section.
From the reviews of the First Edition:
“Everitt & Wessely are to be congratulated on producing an excellent guide to help overcome the snags in clinical trial research. Clearly written and in an engrossing style, the book is likely to become a classic textbook on clinical trials, and not just in psychiatry. The authors’ enthusiasm and grasp of clinical trial research make for a gripping and insightful read…it is one of the very best books that has been written on clinical trials.” THE BRITISH JOURNAL OF PSYCHIATRY
"The experience of both authors in this area gives the book a very pragmatic approach grounded in reality, with theoretical overviews invariably being followed by practical examples and applications… an invaluable companion to anyone involved in, or contemplating undertaking, clinical trials research.” PSYCHOLOGICAL MEDICINE
Editorials
From the Publisher
"A book to read from beginning to end.... Clinical Trials in Psychiatry covers all the most important issues and will be useful to all clinicians who are involved in conducting, or using the results of, clinical trials. It provides a highly persuasive account of the unique scientific advantages of randomised trials for those who remain unconvinced. It is very readable." (British Journal of Psychiatry, February 2009)
"On balance, readers looking for a practical text to introduce them to the key issues will be well-satisfied with Clinical Trials in Psychiatry." (Journal of Biopharmaceutical Statistics, Volume 19, Issue 1, 2009)
"On balance, readers looking for a practical text to introduce them to the key issues will be well-satisfied with Clinical Trials in Psychiatry." (Journal of Biopharmaceutical Statistics, Volume 19, Issue 1, 2009)
From The Critics
Reviewer: Michael Joel Schrift, D.O., M.A.(University of Illinois at Chicago College of Medicine)Description: This is the second edition of a concise review of the clinical trial literature for psychiatric research. Although the authors admirably address most of the important issues that are involved in performing clinical trials in psychiatry, they seem to either ignore or ride roughshod over such critical issues as therapeutic misconception (an all too common problem regarding informed consent in psychiatric research), psychiatric diagnostic validity (relies on imprecise, variably applied, and unstable diagnostic criteria with the division of psychiatric disorders into discrete categories based on discussion and consultations among designated experts in the field and based on a consensus by these designated experts, not on experimental evidence), and the enormous problem of research conflicts of interest (although briefly mentioned, given short shrift). This review book, which was written and edited by experts in the field, would have been excellent were it not for the above omissions.
Purpose: The purpose, according to the editors, is "to provide a relatively concise account of clinical trials in psychiatry for both people contemplating undertaking a clinical trial, and those seeking to interpret results from such a trial." Unfortunately, the next sentence seems to reflect an attitude that permeates their review: "As bureaucracy threatens to make the former [undertaking a clinical trial] more difficult, we hope this book will at least simplify the latter." It seems this book was simplified too much!
Audience: The audience includes anyone who is interested in the conduct of clinical trials in psychiatry.
Features: The first chapter reviews the history of the use of scientific evidence in medicine and in psychiatry in particular. The second chapter focuses on the various aspects of clinical trials including the control group, randomization, allocation concealment and blinding, and phase I - IV clinical trials, as well as an abbreviated treatment of ethical issues. For example, when discussing the Declaration of Helsinki, the authors state: "No trial has ever been performed to prove that penicillin is effective for meningitis and no doctor would have considered taking part if any such trial had ever been suggested." The authors seemed to not have read a paper that every researcher needs to be aware of: "Ethics and Clinical Research" (Beecher HK (1966) New England Journal of Medicine, 274, 1354-1360). Nor was this paper mentioned in the bibliography! The third chapter is an excellent review of design considerations. Issues such as complex interventions and outcome measures are addressed in chapter four. Chapters 5 and 6 are also excellent, providing a clear overview of statistical analysis from a psychiatric trial. The next chapter contains a superb discussion of meta-analytic and systematic reviews. The final chapter discusses all, too briefly, the threats, challenges, and future of clinical trials. The appendixes are somewhat useful, although a discussion of institutional ethics review boards seemed to have been omitted. The appendix addressing software recommendations is helpful.
Assessment: This second edition contains several excellent chapters, but because of its significant omissions, I cannot recommend spending the $90 for its purchase.
3 Stars from Doody