[Good clinical practice:impediment of source of progress?].
On the bases of the Declaration of Helsinki (1964), the law called Huriet-Sérusclat (1988) and several subsequent decrees have clearly defined the appropriate organization and management of clinical trials in France. The law on the Commission de l'informatique et des libertés (1978) and several European regulations have also to be taken into account. This extensive legal and regulatory system has been the source of a major improvement in the scientific quality of clinical trials and in the security of participating persons. Indirectly, it has also improved daily clinical care, as physicians have learned how to inform their patients and have been trained to use protocols and standard operative procedures. However, the legal and regulatory pressure has increased the cost and complexity of trials to such an extent that no clinician with his own resources is now able to be the sponsor of a trial involving more than a few patients. In addition to trials organized by pharmaceutical companies for drug development, health authorities in France and Europe should consider to support major clinical trials on therapeutic strategies with public health implications. A few examples can be acknowledged thus far, but a real policy remains to be defined.
Dormont
J
J
Agence nationale de recherches sur le sida, Paris.
D002986:Clinical Trials as Topic; D004345:Drug Industry; D004992:Ethics, Medical; D005602:France; D006801:Humans; D007258:Informed Consent; D011634:Public Health; D011786:Quality Control; D012107:Research Design
Bonnes pratiques cliniques: frein ou source de progrès?