Good Clinical Practice Journal

Below are the titles of articles published in the Good Clinical Practice Journal Volume 8 Issue 1 (January 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 will be publishing regular Comment from our readers, in response to articles published elsewhere.

We start this month with a letter published by The New England Journal of Medicine 2000; 343: 808-810 by Dr Donna Shalala, entitled 'Protecting research subjects: what must be done'.

Dr Shalala is the US Secretary of Health and Human Services and her article was written in response to a tragic event that took place during a gene-transfer trial and the chain reaction that followed. Plenty of irregularities were brought into open and non-compliance with ICH GCP guidelines was highlighted. Americans woke up to the news that clinical research conducted in their most prestigious universities is not doing enough to protect volunteers and a young man has died as a result.

We feature comment by Stephen DeCherney, Charles Pierce and Nigel Crossland. Nigel Crossland is an International quality advisor and runs Crossland Consultancy, a Quality Management Consultancy specialising in clinical research audit and providing advice and training in pharmaceutical and medical device R&D in the UK.

Dr Charles Pierce is a Pharmaceutical Medicine Consultant in the US, with a vast experience in research activity and application.

Dr Stephen DeCherney is Executive Vice President for Clinical Operations at Pharmaceutical Research Associates International in the US. He is the author of more than 60 publications and has been principal investigator on more than 100 research programmes.

"Clinical trials in the USA"
by Brian Donato and Thomas Gibson

Abstract
The regulatory requirements established for studies in the USA are, with few exceptions, generally the same as those the US FDA applies to studies conducted elsewhere in the world which are offered in support of an FDA approval. For that reason, it is essential for anyone involved in such studies anywhere in the world to know what the FDA expects, especially when, as now, the FDA is expressing concern about the competence and integrity of such trials, and appears to be redoubling its efforts to scrutinise them.

"Web-based clinical trials: the way forward"
by Shiv Tasker, Paul Bleicher and Michael Ball

Abstract
Upgrading from a paper-based data management system to a Web-based electronic information system can help pharmaceutical companies increase the efficiency of their clinical trials. The time required to lock and clean a database after last patient visit can be virtually eliminated. Decisions about investigator recruitment and drug logistics can be made earlier. Patient safety can be enhanced through early, automated notification of serious adverse events. In the clinical trial planning phase, clinical teams can use collaborative software to review the design the forms that will be used in electronic clinical trials. During and after the trial, trend analysis techniques can be used to improve site performance and detect fraud. All of these benefits combined have an enormous impact on the efficiency and quality of the clinical trial.

"The future of clinical research is Europe"
by Cathy Dove

Abstract
The idea of no clinical research being conducted within Europe is a preposterous one.

"The future of clinical research is [not] Europe"
by Angus Donald

Abstract
The issue placed before a recent Institute of Clinical Research audience was where it is now most practical to conduct clinical research (as opposed to where we might like to conduct it). It was Angus Donald's (dubious) honour to be the first to attempt to convince attendees to pack their bags and mortgage their houses. In the spirit of the occasion, here is the case he made.