Good Clinical Practice Journal

Below are the titles of articles published in the Good Clinical Practice Journal Volume 8 Issue 4 (April 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 medical literature. This month's Comment features an Opinion published in Scrip Magazine October 2000 by Dr Philip Brown, the publisher of Scrip World Pharmaceuticals News. The article 'E-pharmacy: love it or hate it, the genie is out of the bottle' was written in the aftermath of the annual congress of the Federation International Pharmaceutique where Dr Brown was the moderator for the FIP Leadership Conference. The topic � e-pharmacy �is enshrouded in mist for most European pharmacists, and caused a great stir that culminated with a rhetorical phrase from Christine Glover, the president of the Royal Society of Great Britain: 'What are we to do now that the genie is out of the bottle?'. In response to the European 'unscrupulous suppliers', 'counterfeit drugs' or 'disintermediation consequent on the establishment of e-pharmacy', the audience was referred to the American outlook - 'you don't know until you buy it'.

We feature comment by Dr Stephen DeCherney, executive vice president for clinical operations at Pharmaceuticals Research Associates International in the USA. Dr DeCherney sees e-pharmacy as an opportunity to improve patient care and lend a hand to both prescribers and pharmacists. Dr DeCherney foresees the worldwide availability of medication lists on a global database. E-pharmacy could create a competitive market where drugs will reach the right patients instantly and effectiveness could be monitored in real time. Maybe his three wishes would come true sooner than we might think.

Dr Paula Hensler
Editor

"SMOs and their impact on clinical research"
By Tristan Brittain-Dissont

Abstract
As clinical R&D enters the new millennium, a number of clear developmental trends are dominating strategic and corporate clinical research planning. Two of these trends, e-enablement and pharmacogenomics, should be recognised for their importance in assisting clinical research. A more prosaic development, the planned massive growth in new chemical entities, constitutes a serious challenge to the logistical processes of clinical research departments.

"Auditing global clinical trials"
by Janet Scotton

Abstract
These days it is likely that data from any clinical trials potentially could be used to apply for marketing authorisation of a drug anywhere in the world. But does it make it a global clinical trial? Probably not.

"Ensuring compliance with GCP in non-pharmaceutical industry-sponsored research"
By Dr Malcolm VandenBurg

Abstract
Exclusive. ICH GCP is coming your way. Where are the resources to ensure quality assurance of non-industry-sponsored clinical trials? Or does GCP mean something different for different types of trial?

"A guide to designing pivotal trials in the USA"
By Cynthia Fink and Karen Becker

Abstract
Undertaking a clinical development programme leading to approval or clearance of a product in the US requires a significant expenditure of resources and time. In most cases, a single carefully planned and conducted clinical trial is all that separates a successful product registration from an extended, expensive, frustrating failure. Experienced planning and conduct of a clinical research programme will avoid duplicative or ineffectual effort, with attendant delays and lost revenue.

"Clinical Trials in South Africa"
By Elizabeth Nettleship

Abstract
A snapshot of South Africa reveals a large country with a population of around 45 million. The challenge is conducting trials ethically in what can be a relatively complex environment.