Good Clinical Practice Journal

Below are the titles of articles published in the Good Clinical Practice Journal Volume 8 Issue 2 (February 2001).

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

"NOTE FROM THE EDITOR"

GCPj is publishing a regular Comment column from our readers, in response to articles published in the general medical literature. We continue this month with an article published in the Journal of the Royal Society of Medicine 2000;93: 511-512 by Dr Nick Nunn et al, entitled 'Cots of seeking ethics approval before and after the introduction of multicentre research ethics committees'.

The authors are members of the Drug and Safety Research Unit and their article is about two studies that requested local research ethics committees (LRECs) and multicentre research ethics committees (MRECs) approval. The studies were industry sponsored. Both applied for LREC and MREC approval, first during 1996 and early 1997 and the second during 1999. The authors approached 21 LRECs out of 197 LREC applications for MICA study, and 1 MREC and 26 LREC for the Evohaler validation Study.

So what is really happening in term of costs? MRECs were introduced in the UK in 1997 to sort out ethics approval for studies conducted in areas within five or more LRECs. The new system was supposed to reduce the cost for seeking LRECs approval, but when the authors looked at numbers, the results were opposite, due to differences in charges and administrative costs.

We feature comment by Dr Douglas Mackintosh, president of GCPA, Fairfax, Virginia, USA. Dr mackintosh approached the paper from the US perspective and makes an analytical comment on the UK position. He questioned the role of ethics committees in his paper 'Ethics Committees do not sufficiently protect research subjects' published in the European Pharmaceutical Contractor', August 1999,pp16-17.

Dr mackintosh has led over ten GCP training workshops for the pharmaceutical industry. He is the principal investigator on a recently awarded NIH grant to develop advanced graphics software to assist clinicians/epidemiologists perform causality analysis on adverse events.

On a personal note, I am looking forward to 2001 as it was recently announced in The Lancet, Vol 357, January 13, 2001, that this will be the year for 'the development of ethical guidelines on international collaborative health research'. Guidelines are to be renewed by both UK and UK ethics bodies, and by the Council for International Organisations of Medical Sciences (CIOMS). Everything is possible and we can assure our readers that all procedures will be announced in GCPj.

Paula Hensler

"Clinical Trials in China" by Dr Gamal Hammad
Abstract
China is well known for its past and still growing population. This article brings information about the requirements of clinical research in China and how we are understand the realities of an expanding industry in a not-so-open market. Dr Gamal Hamad tells us why China is the land of opportunities.

"Training-more than just a regular dose of GCP?"
by David Montgomery
Abstract
ICH GCP requires sponsors to provide training for all their staff involved in the conduct and reporting of clinical trials and, to some extent, also for investigators. However, it is for sponsors to determine how this training should be organised, delivered, recorded and evaluated. Training is something that must be shared equally between all stakeholders and is not the sole responsibility of a trainer or group of trainers.

Agreement on what training is, or should cover, can vary widely. Indeed, expertise and training content is frequently given more attention than the selection of, and appropriate guidance for trainers.

"Ethics by partnership: an imperative for the future of pharmacogenomics"
by Professor Deryk Beyleveld
Abstract
The culture of regulation and ethical oversight of research needs changes. Now is the time for research ethics of partnership and for clinical practice to follow research ethics. This article brings forward the idea that ethics is the piece de resistance for the scientific and clinical education of researchers and clinicians.

"Update on the National Institute for Clinical Excellence (NICE)"
by Brian Lovatt and Fred Mills
Abstract
The long-awaited guidelines for the submission of dossiers for consideration by NICE have not yet appeared in their finished form, but consultation documents have been issued which point the way forward. We must stress that, at the time of writing, the definitive guidances were not yet known.