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Is it a Problem? Foreign Trials for Drugs Sold in U.S
Just where was your new drug tested? A new report by Daniel R. Levinson, the inspector general of the Department of Health and Human Services, spells out new concerns about new drugs whose human trials took place in foreign countries where federal auditors could not make sure patients were protected.
According to a report 80 percent of the drugs approved for sale in 2008 had trials in foreign countries, and 78 percent of all subjects who participated in clinical trials were enrolled at foreign sites. Ten medicines approved in 2008 were tested entirely abroad with not a single test patient in the United States, the report said.
Central and South America had the highest number of subjects per site and accounted for 26 percent of all subjects enrolled at foreign trial sites. In 2008, the Food and Drug Administration inspected 1.9 percent of domestic clinical trial sites, while just 0.7 percent of foreign clinical trial sites were similarly audited.
“I think this report just confirms the potential problems with foreign trials,” said Dr. Adil E. Shamoo, editor in chief of Accountability in Research, a journal about research ethics. “There is less liability, patient recruitment is far easier, the concept of informed consent is not well established, and it’s cheaper.”