Raising alarms, study sees trials migrating abroad

The U.S. drug industry has shifted most of its clinical trials to overseas sites in a trend that experts warn raises serious ethical concerns. According to a study in the New England Journal of Medicine, 13,521 of 24,206 trial sites being sponsored by the top 20 U.S. drug companies in late 2007 were taking place beyond our borders, where data can be harvested cheaper and faster than the data gathered inside the U.S. And the study adds that the number of countries hosting trials has doubled in 10 years.

One reason why researchers often prefer an international group of subjects for a clinical trial is that many are treatment "naïve," meaning that they aren't taking another drug for their ailment. But the researchers also say that recruiting patients abroad often entails enlisting people to study experimental drugs that they could never afford. And they warn that one reason why trials in some countries are significantly cheaper is that there is much less oversight. One study concludes that only slightly more than half of the 670 researchers conducting trials abroad had gained official approval for their work.

"Clearly there are major challenges both in terms of ethical oversight of the research and the scientific rigor," said Seth Glickman, an assistant professor of emergency medicine at the University of North Carolina-Chapel Hill.

- read the article in the Wall Street Journal

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