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FDA should beef up its oversight of clinical drug trials conducted outside the U.S., a report from the inspector general of the Department of Health & Human Services concludes. The report estimates that 80% of drugs approved in 2008 by FDA contained data from foreign clinical trials. Drug trials are often cheaper to conduct in foreign countries, and larger trials can be conducted in less time, the report suggests. Most of the foreign trials were conducted in Europe, where ethics controls are similar to those in the U.S., but some took place in Central and South America, where ethics controls are less robust. FDA inspected only 0.7% of foreign clinical trial sites and 1.9% of domestic clinical trial sites in 2008, according to the report. The agency may be unaware of some early-phase clinical trials because sponsors are increasingly conducting them outside the U.S. without notifying FDA, the report finds. The report suggests that FDA require standardized electronic clinical trial data and create an internal database.
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