Over the past decade, biopharmaceutical companies
have increasingly turned to emerging markets as a way
to reduce clinical trial costs and timelines. Areas such
as Eastern Europe, India, and Latin America—with their
ready population of treatment naďve patients—can be an
answer to the intense competition for patients seen in
developed markets. Many of the countries within these
regions may now be considered as “emerged” countries
but yet, conducting trials in these regions does require
some special attention and expertise. Before deciding to
conduct studies in these areas, companies should have a
full appreciation for the ethical, medical, regulatory, legal,
and operational hurdles that must be surmounted for
success. Here we highlight a number of those issues and
offer our recommendations for how sponsor companies
can deal with them effectively.
The Allure of Emerging Markets
Sponsors’ interest in emerging markets as loci for
clinical trials has been mounting for at least a decade.
(See Figure 1A and 1B.) In 2011, this phenomenon
reached a tipping point: for the first time, more data
were submitted to the European Medicines Agency in
marketing-authorization applications on patients from
outside of Europe and North American than from within
those areas. While the “Rest of the World” designation
includes some mature markets such as Australia and
Japan, there is, nonetheless, a clear takeaway: emerging
markets have become a hot bed of trial activity.
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