HER2 Support Group Forums - View Single Post - FDA Scraps Helsinki Declaration on Protecting Human Subjects

gdpawel · 05-09-2008, 12:09 PM

The FDA formally declared that it will no longer require that clinical trials submitted to the agency to get regulatory approval for a new drug adhere to the Helsinki Declaration.

The new rule, which goes into effect next October, was supported by the drug industry but opposed by numerous public interest, patient advocacy, and consumer groups.

The new rule requires only that trials conducted abroad by drug manufacturers follow good clinical practices (GCP) and include a review and approval by an independent ethics committee.

There's nothing in GCP guidelines that requires patients in the control arm of a trial get access to already proven therapies.

http://www.gooznews.com:80/archives/001052.html

This article explains the significance of the FDA decision.

http://www.nature.com/embor/journal/...l/7400743.html

05-09-2008, 12:09 PM	#1
gdpawel Senior Member Join Date: Aug 2006 Location: Pennsylvania Posts: 1,080	FDA Scraps Helsinki Declaration on Protecting Human Subjects The FDA formally declared that it will no longer require that clinical trials submitted to the agency to get regulatory approval for a new drug adhere to the Helsinki Declaration. The new rule, which goes into effect next October, was supported by the drug industry but opposed by numerous public interest, patient advocacy, and consumer groups. The new rule requires only that trials conducted abroad by drug manufacturers follow good clinical practices (GCP) and include a review and approval by an independent ethics committee. There's nothing in GCP guidelines that requires patients in the control arm of a trial get access to already proven therapies. http://www.gooznews.com:80/archives/001052.html This article explains the significance of the FDA decision. http://www.nature.com/embor/journal/...l/7400743.html