Good Clinical Practice Journal

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

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

Note from the Editor
It is difficult to discuss clinical trials without mentioning the use of placebos. Most of us have been told in medical school how important placebos are in the development of new drugs. The question is: who said so? Two Danish doctors, Asbjorn Hrobjaartsson and Peter Gotzsche, have analysed 130 clinical trials that compared placebo with no treatment, looking at continuous and binary outcomes. In these trials, the placebo was represented by either pharmacological means such as tablets, physical means like manipulation or psychological ones, for example, a conversation. The results brought a surprise: placebos do not have powerful clinical effects according to the evidence found. However, some benefits were find from studies with continuous subjective outcomes and for the treatment of pain. The article 'Is the placebo powerless?' was published in the New England Journal of Medicine on 24 May 2001 and had a strong editorial to support its findings. Dr John Bailar entitled his editorial 'The powerful placebo and the wizard of Oz'. The article and editorial seem to support the revised Declaration of Helsinki position on placebo. We hear another story from the regulatory authorities. The FDA considers placebo-controlled clinical trials the 'gold standard' and, recently, the EMEA gave a similar signal.

Nigel Crossland is an independent quality advisor with Crossland Consultancy, a Quality Management Consultancy specialising in clinical research audit.

The assessment of cognitive function in clinical trials
By Prof. Keith Wesnes
Abstract
It is difficult to overestimate the need for the definitive evaluation of cognitive function throughout the drug development process. It is necessary that those responsible for assessing cognitive function, ie. psychologists, properly define the role of cognitive function in everyday behaviour, develop appropriate measures and apply them to clinical trials

Biotech medicines: at the confluence of innovation and clinical research (part I)
By Cecil Nick
Abstract
Biotechnology is having a major impact on expanding the boundaries of medicine, enabling the unlimited supply of many therapeutic proteins as well as the manufacture of improved and even novel proteins.

Healthy volunteers as research subjects: who protects the subjects from themselves?
By Paul Price
Abstract
Phase I clinical pharmacology studies are the first stage of evaluating medicines in human subjects, prior to medicines being used in patients. Phase I clinical trials explore the safety ands establish the level of knowledge of drugs in human subjects, and as such are some of the most important studies to be conducted in a clinical research programme.

Using the Internet as part of a coordinated patient recruitment strategy (part II)
By Dan McDonald
Abstract
In the past several years, the Internet has gained credibility as a viable patient recruitment resource. Although the incidence of Internet usage to recruit patients is relatively low at this time, clinical research professionals � in sponsor and CRO companies as well as in investigative sites � have began to see dramatic increases in usage.

Why should you work under a US IND outside the USA? (part II)
By Debra Baker and Genevieve Decoster
Abstract
The aim of this article is to outline the process of working under a US IND within and outside the USA and to discuss two common problems in global development programmes. These are the acceptability of foreign data for US regulatory submissions and whether it is necessary to generate these data under a US IND or if there are other acceptable alternatives.