Foreign trial data used in 4/5 of approved drugs

FairWarning’s Lea Yu and The New York Times‘ Gardiner Harris drew our attention to a report from the HHS Office of Inspector General which reviewed 2008 data and found that “Eighty percent of approved marketing applications for drugs and biologics contained data from foreign clinical trials.” Furthermore, the OIG found, “Over half of clinical trial subjects and sites were located outside the United States.”

The OIG expects the trend to grow in the future, writing that “Western Europe accounted for most foreign clinical trial subjects and sites; however, Central and South America had the highest average number of subjects per site.”

The FDA only inspected a minuscule percentage of these foreign test sites, but says it has taken the OIG’s advice and is stepping up efforts to put together agreements with its foreign counterparts and to figure out other methods to standardize and evaluate these foreign trials.

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