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
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