The Pharmaceutical Journal
Vol 270 No 7249 p697
17 May 2003

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Some pharmacy and industry input would make this a better buy

‘The handbook of clinical trials and other research’, by Alan Earl-Slater. Pp vi+352. Price £29.95. Oxford: Radcliffe Medical Press Ltd; 2002. ISBN 1 85775 485 9.

Is it a textbook, a reference book, a guidebook or a dictionary? With an alphabetical layout of topics followed by definitions, which are usually quite detailed, it must be a dictionary. This format is well suited to the main role of the book and links to related topics and definitions are provided in bold type at the end of each entry.

Those who, like me, came fresh to clinical trials and research with only the most basic knowledge of good manufacturing practice, find the plethora of acronyms, terminology, regulations and personnel overwhelming and so a book of definitions, roles and responsibilities is overdue — but is this the one we have been waiting for? The publication date is 2002 so I expected to find definitions of the National Institute for Clinical Excellence (yes), the governance arrangements for NHS research ethics committees (GAFREC) (no) and details of the European Union Clinical Trial Directive (yes, but).

Here is the main fault with this book — the description of this important document relates mostly to its effect on ethical and National Health Service issues and hardly at all to those impacting on the pharmaceutical industry in relation to good manufacturing practice, the approval of phase I studies and the abolition of the DDX and CTX process (definitions of these terms are also missing).

I searched in vain for a definition of clinical trials pharmacist or their role in trial preparation or in drug accountability. Definitions of study site co-ordinator and research nurse — the personnel who actually deal with the patients or volunteers — were also missing, along with the current buzzword “fourth hurdle”.
This book will disappoint industry personnel — pharmacists will be outraged. It is worth putting on your bookshelf for reference, but a second edition, with industry and pharmacy input, would make this a much better buy.

Alan George