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. 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,” The Nation writes.
According to the report, “Central and South America had the highest number of subjects per site and accounted for 26 percent of all subjects enrolled in foreign trials,” the magazine adds. “What’s worse, the dramatic rise of offshore clinical trials has coincided with a loosening of standards guiding their practice,” The Nation writes (Hearn, 9/21).