Good Clinical Practice Journal

Below are the titles of articles published in the Good Clinical Practice Journal Volume 8 Issue 3 (March 2001).

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

"NOTE FROM THE EDITOR"

This month GCPj presents a comment from Dr David Galloway, Director of the medicines Assessment Research Unit in Aberdeen, UK on an article published in the Journal of the Royal Society of Medicine, 2000; 93: 555-556. The article, 'It's official: evaluative research must become part of routine care in the NHS' by Professor Iain Chalmers, is a pertinent signal for those involved in academic/NHS research that adherence to Good Clinical Practice is essential. The National Health Service (NHS) R&D programme stresses the importance of conducting research for any health professional and/or manager. Prof. Chalmers' analysis of the NHS Plan refers to the Government's opinion on clinical research, for example, the necessity for informed consent in controlled clinical trials. The plan only mentions the new NHS Cancer Research Network. The article explains the reasons behind introducing evaluative research as the basis for routine care in the NHS and suggests sound procedures to implement these changes.

Dr Galloway's comment reviews different aspects of the programme and presents the Scottish perspective of the NHS R&D. He questions how all these principles will be introduced in the day-to �day practice, bearing in mind the failure of former intentions such as those in the Culyer report of 1994. The Scottish NHS appears to be ahead of England and Wales regarding GCP promotion, through the Scottish Intercollegiate Guidelines Network (SIGN). Prof. Chalmers and Dr Galloway find themselves on common ground when they discuss financial resources.

"Phase I clinical pharmacology studies � a question of consent"
by Paul Price

Abstract
The healthy volunteer � the ultimate Guinea Pig? The purpose of this article is to explore the wide variety of models adopted when screening assessments for participation in Phase I studies.

"Exploring issues in multinational patient recruitment"
by Diana L Anderson PhD

Abstract
In the twenty-first century, patient recruitment is a complex and challenging issue. Here Diana L Anderson PhD discusses the need for strong guidelines in multinational patient recruitment that prove their safety and efficacy.

"Accommodating genotype differences in clinical trials"
By Roy Pettipher, Diana Schuette and Nigel Amphlett

Abstract
Understanding the diversity of the recently sequenced human genome will provide opportunities to identify a plethora of new therapeutic targets. This review discusses how pharmacogenomics � using gene sequence information to predict response to drugs � can be used to extract the full value from clinical trials.

"Patient involvement in clinical trials of potential cancer therapeutics"
By Professor Patrick Johnston and Sister Ruth Boyd

Abstract
Patient participation in all phases of cancer clinical trials is essential for advances in cancer treatment, improvements in cancer patient outcomes and enhanced quality of patient care. A partnership approach is being pursued and opportunities for patients to participate throughout the clinical trial process are advocated.