Good Clinical Practice Journal

Below are the titles of articles published in the Good Clinical Practice Journal Volume 5 Issue 5 (September/October 1998).

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

"WHO and global harmonisation - is it a dream come true?"
by Dr Juhana E Idänpään-Heikkilä

Abstract
This article outlines the historical background of the WHO and ICH, the fundamental differences between the harmonisation activities of the two organisations and the prospects for comprehensive harmonisation encompassing all aspects of regulatory requirements and procedures.

"Testing of drugs in specialised groups"
by Dr K L Rost, Professor H Fuder and Professor W M Herrmann

Abstract
The pharmacokinetic and pharmacodynamic profiles of various subpopulations are discussed. Reference is made to those specialised groups defined in the ICH guidelines, i.e. pregnant or lactating women, children, the elderly, ethnic minorities and patients with renal or hepatic impairment.

"Why do clinical trials in Russia?"
by Dr Martin Bitsch

Abstract
This article assesses the potential for conducting clinical trials in Russia, and examines the national healthcare structure, resource availability, patient population, documentation and approval procedures. The author discusses the disparities between clinical trials in Western Europe and Russia, and looks at the implications thereof and ways of resolving these apparent hurdles to conducting of a successful trial.

"A European experience"
by Fiona Jones

Abstract
In this article two research scientists talk about their experiences of moving abroad to work in pursuit of their respective career goals. The article examines their motives for moving, their initial impressions of the foreign country, the main problems they faced and how these were overcome. They also offer advice for scientists faced with similar opportunities and examine the fundamental differences in attitudes towards working practice in England and France.

"Evidence based clinical practice guidelines - who benefits?"
by Professor Allen Hutchinson

Abstract
In this article clinical practice guidelines are defined and examined in terms of their principal and subsidiary functions, the potential benefits for clinicians, patients and the health service industry. Advice is given regarding implementation of new guidelines.

"The drive to gain recognition"
Dr Gamal Hammad interviews Professor Peter Stonier

Abstract
Becoming recognised as a medical Specialist Training Authority by the Royal College of Physicians will be a vital step in the life of the Faculty of Pharmaceutical Medicine. It could mean the difference between having a respected public face, and relative obscurity. The Faculty's President is Professor Peter Stonier - a man who is involved in pharmaceutical medicine at many levels. In this interview given almost a year after his inauguration, he talks openly about his work, dreams, and in particular the influence he believes the Faculty of Pharmaceutical Medicine could have not only within the UK but in the wider and changing world of clinical research, drug development and healthcare.