Globalization of Clinical Trials

Reuters has a special investigative report on globalization of clinical trials.  Big Pharma’s Global Guinea Pigs, by Ben Hirschler, examines the “offshoring” of clinical trials to countries in Asia and Eastern Europe.  Numerous “push” and “pull” factors are leading to globalization of clinical trials.  Reduced costs, lower regulatory standards, and ready access to “treatment naive” populations are leading pharmaceutical companies and CROs to conduct trials in such countries as China, Hungary, and Poland.  In addition, companies hoping to market products in “emerging economies” attempt to break into these markets by conducting clinical trials and satisfying regulators in these countries.  Clinician-researchers in the U.S. express ambivalence about the shift.  Some researchers express concerns about quality of data obtained in low-cost settings.  Other biomedical researchers complain about the administrative burden associated with conducting clinical trials in the U.S. and see the offshoring of drug studies as the only affordable way to run large-scale clinical trials.    Send article as PDF