(1997; 248 pages) [French]
1.7 Authorization of clinical trials
A small authority may occasionally need to consider an application to conduct a clinical trial of an unregistered drug in the treatment of a condition that has a high local prevalence. To provide for this contingency, the registration system should include provision for the importation of the necessary materials, subject to appropriate controls. Such trials should only take place after formal clearance has been obtained from the competent registration authority and after assurances have been obtained that they will be conducted in conformity with the principles contained in the World Medical Association’s Declaration of Helsinki and the Proposed International Guidelines for Biomedical Research Involving Human Subjects issued by the Council for International Organizations of Medical Sciences.1 WHO stands ready to offer independent technical advice to national authorities in these circumstances.
1 Council for International Organizations of Medical Sciences. Proposed international guidelines for biomedical research involving human subjects. Geneva, 1982 (also contains the Declaration of Helsinki as revised by the 29th World Medical Assembly, Tokyo, 1975).