Guarding Against Bribery When Conducting Clinical Trials Overseas

By: Jacqueline C. Wolff
– The FCPA Report

Clinical trials sponsored by pharmaceutical and medical device companies are generally intended to obtain data to support applications to the FDA for the approval of new drugs or devices or the approval of new indications or uses for currently marketed drugs or devices. In an effort to cut down on costs, life science companies based in the United States are increasingly conducting their clinical trials overseas. As of 2010, 80% of applications to the FDA for drugs and biologics contained data from overseas trials and 78% of the trial participants were enrolled outside of the U.S. Trials of biologics alone had an even higher percentage of overseas enrollees. From 2010 to 2014, the rate of overseas investigators increased, whereas the rate of U.S. investigators decreased. Many of these trials are being conducted in Russia, India, China and Brazil, countries where the risk of corruption is high. This shift requires implementation of, and strict adherence to, anti-corruption compliance policies and procedures. Indeed, the need to be vigilant is further heightened by the fact that the U.S. government's oversight of overseas trials may well increase in the future.

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