The Pharmaceutical Journal
Vol 272 No 7301 p681
29 May 2004

Clear exposition of clinical trial procedures but update urgently needed

‘Guide for clinical trial staff: implementing good clinical practice’, by Gerhard Fortwengel. Pp vi+108. Price E28. Basel: Karger; 2004. ISBN 3 8055 7655 2

Clinical trials are becoming more commonplace, both in primary and secondary care, and there has been a need for a clear, stepwise introduction, guide and aide-memoire for investigators to the intricacies of the regulations enshrined in the International Conference on Harmonisation guidelines for good clinical practice (ICH/GCP).

Publisher and author have combined to produce a well laid out, clear and user-friendly guide to all the key stages of the clinical trial process, with frequent and relevant reference to ICH/GCP. The stages of each process are explained with key, numbered, steps with tick boxes and checklists to record progress.

Despite the book’s 2004 publication date, there is no mention of the EU Clinical Trial Directive (active from May 2004), which has been in existence since 2001. This makes several of the sections, especially those relating to ethics and ethics committees, already outdated. There is also no attempt to highlight differences between US (Food and Drug Administration) regulations and the EU. It would also have been more useful if the various roles of the investigator’s team had been described, for example the role of the clinical trial pharmacist in drug accountability.

This is a clear exposition of clinical trial procedures and operations but an update is urgently needed.


Alan George

Alan George is reader in clinical pharmacology and director of clinical researcher courses at Liverpool John Moores University