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International Clinical Trials

The Search for Research

Principles and Practice of Clinical Research covers a lot of ground but fails ultimately to impress, writes Graham Hughes

It is a daunting task to attempt to review a 700-page tome on clinical research in 400 words. That being said, as well as giving a general description of the book in its present edition, there are a few useful comments that can be made on its content, which unfortunately leaves a lot to be desired.

Firstly, though, we should look at what the book does cover. The edition provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. It is some 300 pages longer than the previous edition and incorporates new chapters on: Managing Conflicts of Interest in Human Subjects Research; Clinical Research from the Patient’s Perspective; The Clinical Researcher and the Media; Data Management in Clinical Research; Evaluation of a Protocol Budget; Clinical Research from the Industry Perspective; and Genetics in Clinical Research. It also delves into data management and addresses how to collect data and use it for discovery (although the increasing trend towards running adaptive clinical trials is not mentioned), and addresses the vast opportunities for the translation of basic science observations to the bedside through clinical research. Molecular medicine, genomics and proteomics have opened up these opportunities.

As an introductory reference, it gives clinical investigators an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements in the US, necessary to maximise the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious fi gures and charts, and sample documents, it serves as a companion text for any university course on clinical research and as a must-have reference for seasoned researchers – but again, in the US only.

As far as readers in Europe are concerned, there are clearly major omissions in the book. How one can talk about the principles and practice of clinical research in this globalised world without mentioning the European Medicines Agency, clinical research in eastern Europe or clinical research in emerging countries such as China, India and Brazil is diffi cult to fathom. I looked in vain for input from organisations who pay for the vast majority of clinical trials: the pharmaceutical industry. Indeed, I believe the title is something of a misnomer and ‘academic’ or ‘research Institute’ should be inserted before ‘clinical research’ in the title. Furthermore, there is very thin coverage of the true practical aspects of clinical trials. CRAs, monitoring, source document verification, quality control, and quality assurance are all notable by their absence.

At €89, this book is relatively inexpensive, but any European reader wishing to use it as a primer on how to run clinical trials, especially in Europe, would surely be sorely disappointed. There is far better guidance on how to carry out the practical aspects readily available.

Principles and Practice of Clinical Research: Third Edition, edited by John I Gallin and Frederick P Ognibene, is published by Academic Press. ISBN 978-0123821676, RRP €89

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