New Book Demystifies The World Of Clinical Trials

Main Category: Clinical Trials / Drug Trials
Also Included In: Pharma Industry / Biotech Industry;  Regulatory Affairs / Drug Approvals
Article Date: 29 May 2008 - 3:00 PDT

email to a friend   printer friendly   opinions  

Researchers, patients, and even clinical trials managers are often bewildered by the Byzantine rules and regulations governing clinical trials. Keeping it all straight and up-to-date has, until now, been challenging. This newly released book, edited by Dr Madhu Davies and Dr. Faiz Kermani, demystifies the topic in an exceptionally reader-friendly, yet authoritative format. "A Quick Guide to Clinical Trials" will allow readers to get a grip on the topic in just enough detail to understand clearly what people are talking about.

"Clinical trials are at the heart of the successful development of new medicines for patients. Like any other specialized area, there is a vocabulary and jargon all its own," explains Dr Davies. "As well as providing an aerial view of the clinical trials process, the book reviews the history of clinical trials, the evolving ethical and regulatory considerations and the commercial angle. The succeeding chapters offer a great nuts and bolts description of the overall process, including how patients are involved, their decision processes, and how they can be affected".

"Unlike other clinical trial books, this one also acknowledges the role of the patient - because without their participation no clinical trial would proceed," adds Dr Kermani. "There is currently a great need for better public support for clinical trials, but this can only happen if both patients and clinical trial researchers fully engage with each other. Many clinical researchers are highly experienced in the operational and regulatory aspects of trials, but how many of them have actually become involved as a patient? The answer is probably very few! To fill this gap this book provides first-hand insights".

A Quick Guide to Clinical Trials is available from BioPlan Associates, Inc., Rockville, MD 20850.
Tel: 301-921-9074 (http://www.bioplanassociates.com)
http://www.bioplanassociates.com/publications/articles/pr-QGCT.pdf

BioPlan Associates, Inc.

• Additional
• References
• Citations