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Monday, Sep 26 2011

The Nation Examines Rise In Unregulated Drug Trials In South America

The Nation examines how a surge in the outsourcing of clinical trials to contract research organizations (CROs) and a resulting increase in the number of trials being conducted in the developing world, where "regulations aren't as onerous, patient recruitment is easier and informed consent is less clearly defined," has led to a rise in unregulated drug trials in South America, noting that, according to a 2010 report by the inspector general of the HHS, "40 to 65 percent of clinical trials on FDA-regulated products in 2008 took place overseas. Of nearly 6,500 foreign trial sites that year, the FDA inspected only forty-five -- less than one percent."
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