March 27, 2005
FDA and Declaration of Helsinki
According to a recent story from Reuters, the Food and Drug Administration has proposed that international guidelines, specifically the Declaration of Helsinki, ethical standards that protect patients involved in clinical trials, should no longer be followed for overseas trials. The Declaration of Helinski guarantees certain rights to patients who take part in a clinical trials, including rights to continued access to drugs at the end of any study, and limitations on the use of placebos in such trials. The Reuters story states,
Currently, FDA rules require studies supporting a new drug application be carried out in line with the declaration or any local laws, whichever is more protective for patients. But proposals made last year would weaken this so that overseas studies not conducted under an application for an investigational new drug need no longer comply with the declaration. Instead, they would simply have to meet good clinical practices. Dr. Robert Temple, FDA's associate director for medical policy, said he felt the "ethical necessities" of a trial were "well-covered" by the good clinical practice standards.
The story is more complex than it originally appears. The blog, Maternal and Child Health, provides a helpful and more in-depth overview of this story and notes that the FDA does not appear to have ever adopted the 2000 Declaration of Helsinki, which is apparently the version of the Declaration at issue. He provides some analysis of why the FDA may feel that the more demanding standards of the 2000 Declaration would overly limit future research opportunities. [bm]
March 27, 2005 | Permalink