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The globalization of clinical research is the new reality. In 2009, fifty million people were enrolled in clinical trials worldwide. Over 31,500 of the approximately 71,400 clinical trials conducted in March 2009 were located beyond the borders of the United States. The largest pharmaceutical companies are expected to conduct up to 65% of their FDA-regulated human trials overseas by 2012, compared with only 44% in 2009. The percentage of clinical trials registered by the FDA conducted outside of the United States and Western Europe went from 5% in 1997 to 29% in 2007. Financing is the main driver behind outsourcing of clinical research. While it costs

A Remedy in Sight: International Clinical Research Regulation in the Wake of Guatemala and Nigeria