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Year : 2011  |  Volume : 133  |  Issue : 4  |  Page : 450-451

Randomized clinical trials design, practice and reporting

Clinical Trials Registry - India, National Institute of Medical Statistics, Indian Council of Medical Research, New Delhi 110 029, India

Date of Web Publication29-Apr-2011

Correspondence Address:
S D Seth
Clinical Trials Registry - India, National Institute of Medical Statistics, Indian Council of Medical Research, New Delhi 110 029
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Source of Support: None, Conflict of Interest: None

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How to cite this article:
Seth S D, Maulik M. Randomized clinical trials design, practice and reporting. Indian J Med Res 2011;133:450-1

How to cite this URL:
Seth S D, Maulik M. Randomized clinical trials design, practice and reporting. Indian J Med Res [serial online] 2011 [cited 2021 Sep 25];133:450-1. Available from:

David Machin & Peter M. Fayers (Wiley-Blackwell, UK) 2010. 361 pages. Price: Not mentioned.

ISBN 978-0-471-49812-4.

In this era of evidence-based medicine, conduct of clinical trials has gained considerable importance. Today, clinical trials are being conducted all over the world to evaluate the efficacy and safety of new treatments by the pharmaceutical industry. In addition, trials are also being conducted to answer questions of academic importance in medical colleges and hospitals. While the Industry is by and large armed with the knowledge and expertise essential for the conduct of clinical trials, those in the academic sector are sadly lacking in these and more often than not are made rudely aware of their shortcomings only after the completion of a "trial" and submission of the manuscript for publication. The book "Randomized Clinical Trials" is just what the doctor ordered, as the book provides an overview of the key issues associated with the design, conduct and reporting of randomized clinical trials. Written in a simple and lucid manner, it is likely to be particularly valuable for the new trialist as it deals with all the components and challenges of a clinical trial.

By their admission, the authors state that "we assume no prior knowledge of clinical trial processes and we have attempted to explain the more statistical sections in as non-technical a way as possible." However, it would be incorrect to assume that this book primarily deals with statistical aspects of clinical trials. On the contrary, the book takes the readers gently through all the diverse steps and processes that need to be considered right from the planning stage, be it elements of protocol writing, ethical clearance, and consent taking, sample size calculation or publication policy.

An introductory chapter explains the basics of a clinical trial using examples as well as touches upon the ethical and regulatory considerations associated with the conduct of a clinical trial. Of the 14 chapters in the book, in about nine the authors have used the commonly applied parallel two group randomized design as the template for discussing key issues ranging from defining carefully the research question posed (and thereby the type of subjects to recruit), the intervention used, the allocation of the trial participants to these interventions, end-point assessment, analysis to reporting. One chapter has been earmarked for outlining the adaptations of the basic parallel two-group randomized trial for repeated measure outcomes and cluster randomized trials, where randomization to the intervention is not made on an individual trial participant basis.

While the two arm parallel group design is most commonly used, there are situations which demand alternatives, such as more than one treatment arm, investigation of a dose response or relate to questions of superiority or non-inferiority. To deal with these situations, a couple of chapters have been dedicated to the discussion of the other available design options such as the cross-over trials and factorial trials, which also describe calculation of sample size as well as methods of analysis.

Guidelines at the end of chapters offer appropriate links and references that must be consulted for the conduct of an authentic clinical trial and the inclusion of statistical tables add value to the book.

A major selling point of this book is its liberal use of examples, which is successful in piquing the interest of the reader while breaking the tedium of a didactic text. Moreover, such examples not only enhance the reader's understanding of clinical trials but also help the reader understand the finer nuances of clinical trial data and appreciate the thought and planning that must be put in before a trial can be launched. The authors have painstakingly used diverse trial examples to effectively illustrate each and every aspect of a trial, including randomization processes, interim analysis. Snapshots of patient consent form; follow up form; surgical complication form, etc., enable the reader to not only comprehend but clearly visualize the entire process of clinical trials and its complexities. The authors are effectively able to drive home the imperative need for a multidisciplinary approach for the conduct of a clinical trial with valid and credible data.

Written by authors with considerable experience in this field, the book is an authoritative guide for clinicians, data managers and medical statisticians involved in clinical trials research.


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