Good Clinical Practice Journal

Below are the titles of articles published in the Good Clinical Practice Journal Volume 8 Issue 6 (June 2001).

Copies of back issues and individual articles are available direct from the publisher � please contact us for further information.

Note from the Editor

We continue this month with our regular column on issues of interest presented in articles from the general scientific literature. This month's Comment features an article published in the New Scientist on 3 March 2001 by Julian Savulescu entitled 'Taking the plug'. Prof. Savulescu is the director of ethics at the Murdoch Children's Research Institute in Melbourne, Australia and a well-known figure in the world of medical ethics.

His article brings to our attention the conundrum faced by people willing to enroll in clinical trials, especially when there is a financial dimension of the problem in the background. Prof. Savulescu is a good advocate for those who support the right to cash incentive and he backs his reasons in a sensible way. The examples he puts forward apply to day-to-day life, making his point of view instantly relevant. The question still remains of where to draw the line between risks and benefits before embarking on a study and to what extent does money modify our perception of high-risk.

Dr Douglas Mackintosh is the president of GCPAudits, Inc in Fairfax, Virginia, USA and has a vast expertise in clinical trials. His Opinion looks at the way ethics committees handle the risks and benefits of a specific study for volunteers. Dr Mackintosh expresses his worries on the possible exploitation of vulnerable populations who will find financial rewards appealing. He hopes that the ethics committees will play a stronger role in weighing how much financial incentives convince volunteers to take part in a trial.
Paula Hensler

Inform your subjects
By Marja de Jong
Abstract
The better informed the subject is at the time of recruitment, the greater the rate of enrolment and the higher the probability of retaining the subject's compliance throughout the trial.

The impact of the EU Clinical Trials Directive on auditing clinical trials in Europe
By Susan Besnard
Abstract
The EU Clinical Trials Directive was, finally, published in the Official Journal of the European Communities on 1 May 2001. The Directive presents a new European framework for clinical trials on medicinal products. Member States have three years to incorporate the Directive into their national laws.

Clinical update in rheumatology
By Dr Margaret-Mary Gordon and Dr Hillary Capell
Abstract
The aims of treatment for rheumatoid arthritis are to reduce pain and disability and to preserve function. The aims are achieved by the concerted efforts of a multidisciplinary team incorporating drug therapy, physical therapy, dietary therapy, podiatry and appliances to aid daily living.

Data warehousing in clinical trials (part 2)
By Jan GM Bakker and Renno Schuurmans
Abstract
Data warehousing is the process of making your operational data available to your business managers and decision-support applications: you conduct better business if you use your data more wisely.

Standard Operating Procedures for Clinical Quality Assurance
By Rick Walsh
Abstract
Clinical Quality Assurance departments exist to provide assurance to the sponsors of clinical research that GCP requirements are being met. They achieve this primarily by conducting audits of particular studies, documents and facilities and, increasingly, of the systems that produce and support these. An essential element of any audit will be a review and appraisal of the relevant SOPs.

Small CROs and their impact on clinical research
By Ignazio di Giovanna
Abstract
It is possible for large and small CROs to coexist and for small CROs to continue to provide sponsors with a highly personalised and specialised service.