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Book Review

Publishing and reporting clinical trials

Interpreting and reporting clinical trials. A guide to the CONSORT statement and the principles of randomised controlled trials. Anthony Keech, Val Gebski, Rhana Pike, editors. Sydney: MJA Books, 2007 (iv + 181 pp). ISBN 978 0 9775786 4 1.

THERE ARE NOW over 30 000 trials published each year (around 80 per day) — a rapid growth since the first randomised trial in the 1940s. Clinical trials are now deservedly influential in both clinical and policy decision making. Hence all clinicians should have a basic understanding of the why, what, and how of clinical trials.Interpreting and reporting clinical trials is an ideal starting point, and has been written by a mix of clinicians, statisticians and data managers with extensive experience in designing and running clinical trials. The basics are well covered: randomisation methods, blinding, sample size calculation, subgroup analysis, intention-to-treat analysis and basic statistical methods. These are explained at enough depth to tell you the difference between a per-protocol analysis and a treatment-received analysis, or what a double-dummy technique is, or how to construct a permuted block design. But the book wisely avoids the complex statistics you would find in more in-depth books such as those by Piantadosi or Freedman.The book is structured around the items in the CONSORT statement: the international standard for the reporting of clinical trials. For those involved in reporting clinical trials, the extra details on presentation are invaluable. The case studies of particular trials, such as PROGRESS, COBALT, BARI, and Post CABG, help illustrate critical concepts in clinical trials and are a novel feature of this unique and readable book.The book is written in a clear and engaging style aimed at both those who simply read reports of clinical trials and those who are involved in conducting them. The explanations are generally excellent; as a teacher of clinical trial methods, there are several expositions that I plan to adopt in future teaching. If you want a good introduction to clinical trials, then this book is a great start at a reasonable price.

Paul P Glasziou

Director, Centre for Evidence-based Medicine
University of Oxford, UK


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©The Medical Journal of Australia 2007 www.mja.com.au PRINT ISSN: 0025-729X ONLINE ISSN: 1326-5377