Key patient safety concern removed in new FDA guidance for non-US trials
The Helsinki Declaration issued by the World Medical Association (1989) was established to guide ethical principles of safety in clinical research and it is therefore extremely worrying that the FDA have removed one of the key recommendations from their guidance on US-based research that is carried out in poor countries.
Opposed by several advocacy groups, regarding use in the US of data collected in foreign clinical trials not under an IND, the rule eliminated the long-standing requirement that such studies must be conducted in accordance with the Declaration of Helsinki, the premier international protection document.
Although not prominently discussed by FDA, one of the principal motivations for their change was a US trade objection to a feature of the Declaration that supports greater access to proven therapies at the conclusion of study in par 30 of the Declaration, which states:
30. At the conclusion of the study, every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic and therapeutic methods identified by the study.
Link to new rule:
http://www.fda.gov/cber/rules/forclinstud.pdf [236 Kb]
AVAC comments against the proposed changes
http://www.fda.gov/ohrms/dockets/dailys/04/sep04/091704/04N-0018-emc00018-01.pdf [48 Kb]