Clinical Trials in Neurologic Practice

December 1, 2001

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-12-01-2001, Volume 8, Issue 12

José Biller and Julien Bogousslavsky, Eds.

Jos Biller and Julien Bogousslavsky, Eds. (Blue Books of Practical Neurology, volume 25, Butterworth and Heinemann, Boston, 2001), 341 pages, ISBN 07-5067-1408, $95.

The stated aim of this collection of essays is to enhance evidence-based medicine decision algorithms for physicians who grapple with neurological disorders. In 15 chapters, an all-star group of authors review current clinical trial practices in neurology and the status of clinical trial evidence for each of the neurological disorders. The presentations are all clearly written, thorough, well-organized, and informative, and the book is well-indexed for retrieval of information on specific topics.

Despite these strengths, the book has weaknesses as a resource to the practitioner. Although the book was published in 2001, the latest dates for references I found were to articles published in 1999. Consequently, new treatments, such as the availability of galanthamine for Alzheimers disease, go unmentioned. Chapters usually do not provide useful information on drugs under development at the time of writing. Facing the intimidating task of managing information, todays practitioner cannot afford to use delayed publications. I found myself looking for other ways that the book could enhance decision algorithms.

In this volume, some authors present succinct summaries of the state of clinical trial evidence in the disease conditions they address because there are few or no trials to reference. Other authors cover many different therapies, each with many different trials, summaries of multiple trials, meta-analyses, and guidelines to consider. Generally the authors offer no systematic critical assessments of the clinical trial sources, no summary recommendations, and no critical reviews of the guidelines produced by expert panels.

The book is a valuable resource for its wealth of information and background offered in many chaptersbut for whom, and for what purpose? Medical students would be better sent to learn how to conduct literature searches to develop the skills they will need to keep up-to-date. House staff should be more current than a book delayed by publication can be. Practitioners can benefit but probably would be specialists in neurology who are managing patients at the depth of the essays. For the practitioner who might want to refer patients selectively to neurological specialists, the lack of practical guidelines and time lapse since the articles were written means the book probably would not provide the support it should. Both nonspecialists and specialists may find this a resource to refresh and order historical memory, but they will want information more up-to-date than the book can offer.

As do most volumes of its type, the book suffers from uneven editing. The problems are minor and not overly distracting. For example, only one topic, myasthenia gravis, is treated in detail in two separate chapters. Authors organized their chapters differently, so there is unnecessary repeated consideration of the same issues of clinical trial design without any systematic attention to how clinical trials might be improved, or how evidence should be evaluated before conclusions are applied to patient care. The editors said they did not intend to be encyclopedic, but the volume is more an aggregation of detailed facts than a dynamic synthesis into an evidence base or a systematic development of algorithms for reaching evidence-based decisions.

Linda Williams opens the volume with a very readable and authoritative review of clinical trial methods useful to both practitioner and researcher. Unfortunately, problems in designing and carrying out neurological clinical trials raised by other authors (Marler, Schluep, and Bogousslavsky, for example) do not receive systematic or unified consideration, and the volume will not methodologically prepare the clinical trials novice beyond the fundamentals of design. On the other hand, many chapters contain a wealth of specifics about problems of treatment and investigation in the different neurological disorders. This would be helpful background to investigators planning a clinical trial. If you are planning an investigation, this book can provide a quick route to a thorough past literature review in many cases and a good beginning in others. If you treat neurological cases, this book will bring you up-to-date as of 1999; the hazard is the temptation to look no further. If you have a specific interest in a rating scale, drug, disease, or the status of research in a particular area, this volume may contain the answer. But because there is no uniform format for all the essays, the depth of treatment of issues varies. Because only some authors report their literature search strategy, it is not always clear whether the content of a chapter reflects the state of knowledge.

I expect that most of us who have attempted to edit a volume or write a chapter have fallen into each of these difficulties; I know I have, and so I congratulate the editors and authors on the quality of their work. How can a volume like this one on widely ranging topics be edited for more uniform and systematic presentation without becoming even more out-of-date by the time it is published? A different approach is needed. At least authors could insist on more rapid publication.

Nevertheless, I can recommend this volume to those who need the type of information presented in it and can understand its limitations. I enjoyed reading almost all the chapters and came away knowing where I can quickly find specific answers and an authoritative background review.

Robert E. Becker, MD, is a consultant developing clinical trial designs.

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