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Quality control, quality assurance, and audit are now an integral, though not always welcome, part of our daily lives. For many years the conduct of clinical trials has relied heavily on trust and the integrity of those involved, and the amount of regulation has been minimal. The introduction of the Declaration of Helsinki in 1964 spelt out the ethical considerations but further changes over the last decade with the introduction of the principles of good clinical practice (GCP) into clinical trials have seen a move towards much closer regulation. References to GCP in this paper relate to research practice in clinical trials and this topic will be examined further in the context of the introduction and implementation of the recent European Community guidelines.1
The initiatives for the introduction of good practice into clinical trials have come from a variety of sources (originally the Food and Drug Administration in the United States, followed by the pharmaceutical industry worldwide, and the European Community). In the UK guidelines were first produced in 1988 by the Association of the British Pharmaceutical Industry (ABPI).2 These guidelines were subsequently adopted voluntarily by the UK pharmaceutical industry. Some European countries then followed with their own version of GCP guidelines, for instance the Nordic Group in 1989.3It is interesting, however, though there appears to be no clear explanation for the fact that while the ABPI refer to ‘good clinicalresearch practice’ and the Nordic Group to ‘good clinical trial practice’, the European Community guidelines drafted subsequently by the Committee on Proprietary Medicinal Products3 just refer to ‘good clinical practice’. These guidelines were approved in July 1990 and became effective on 1 July 1991.
The introduction of national legislation in support of GCP has been gradual throughout Europe and, not surprisingly, there remains some …
Department of Epidemiology and Population Sciences, Medical Statistics Unit, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT
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