WHO has recently convened an informal consultation as a first step in the review of the WHO Guidelines on Good Clinical Practice (GCP) for trials on pharmaceutical products. Participants from Argentina, the European Union, China, Indonesia, Japan, Jordan, Switzerland and the United States of America were drawn from the various related disciplines which are embodied in the scope of good clinical practices.
The purpose of the meeting was to consider the need for a revision of the WHO guidelines with regard to evolution in the state-of-the-art in drug development, pharmacotherapy and clinical research since the publication of the first WHO GCP guidelines in 1995 (1). The meeting objectives were to provide a forum for review, consideration and discussion of actual issues and future needs.
Good clinical practices encompass the design, conduct, monitoring, audit, analysis, reporting and documentation of clinical studies. Application of GCP ensures that the studies are scientifically and ethically reliable and that the clinical properties of quality, safety and efficacy of the pharmaceutical product under investigation are properly documented.
WHO good clinical practices do not constitute the only guidance for the conduct of clinical trials in human subjects. Many countries have devised their own GCP, while other texts include the International Conference on Harmonization (ICH) tripartite guideline on good clinical practice, or the European Council Directive 2001/20/EC relating to the implementation of good clinical practices in the conduct of clinical trials on medicinal products for human use. Participants stressed the importance of keeping the number of GCP texts to a minimum. It urged countries to draw on existing texts wherever possible rather than create individual texts.
The purpose of the GCP guidelines is to provide globally applicable guidance for the conduct of clinical trials, thereby reinforcing the ethical and scientific integrity of research. Participants at the meeting agreed that it is appropriate and timely for WHO to take an active role in this area and that a revision of the WHO GCP guidelines is necessary. Such a revision and its application will also contribute to strengthening public assurance by confirming that the rights, personal integrity, safety and welfare of trial subjects are duly considered.
Participants focussed on the need to ensure confidentiality and informed consent, with particular regard to protection of the vulnerable. The usefulness of GCP guidelines as an educational tool in research was also stressed. Participants also recommended that the scope of the revised WHO GCP guideline should be expanded to include all human research interventions likely to benefit from the application of such guidance. Equally, WHO was urged to develop a new format to facilitate use of the guidelines. Dissemination and promotion of the guidelines and their application could be achieved through the use of new information technology, reinforced exchange of information, and distribution of a GCP CD-ROM, together with training material.
1. World Health Organization. WHO Guidelines on Good Clinical Practice (GCP) for trials on pharmaceutical products. Technical Report Series, 850 (1995) available on http://www.who.int/medicines, and select “documents”.