Kenneth A. Getz
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In 2006, four out of ten (41%) active FDA regulated principal investigators were based outside the United States, according
to an analysis conducted by the Tufts Center for the Study of Drug Development. Since 2002, the number of U.S.-based clinical
investigators filing new Forms FDA 1572 has declined by 5.5% annually. During the same period, the number of active FDA regulated
investigators based outside the United States has grown by 15% annually.
But recent talk about the rapid growth of clinical trial activity overseas belies the realities of conducting studies there.
It is hard to ignore Asia's 29% annual growth since 2001 in FDA regulated investigators, Latin America's 13% annual growth
or Central and Eastern Europe's 16% annual growth when the number of U.S.-based FDA regulated investigators has declined during
that same period. High overall regional growth fails to capture the subtleties and dynamics of individual countries within
each region. Sponsors and CROs need to constantly monitor these details in order to anticipate and manage more effectively
their increasingly global clinical trial activities.
Under the microscope
Take Central and Eastern Europe (CEE), for example. During the past decade, this has been the fastest growing region worldwide
for FDA regulated principal investigators. CEE investigators last year accounted for 1793, or nearly 8%, of total active FDA
regulated investigators. The region has experienced 41% annualized growth since 1996, when it was home to a mere 56 investigators.
CEE offers a high volume of patients and well-trained clinical research professionals as well as cost advantages. A closer
look at sponsor experiences in the region, however, reveals a number of unique conditions and challenges that must be managed.
"CEE countries have made enormous progress," said Andras Madai, MD, Merck's regional medical director for CEE. "Many institutions
in the region are absolutely comparable to Western institutions when it comes to infrastructure for clinical research."
"The region is home to millions of patients, many of them receiving less than optimal health care services and drug therapies,"
said Madai, who was raised in Hungary. "Sponsors can find the patients they need by going to fewer institutions than in the
West. Grant sizes are also smaller as a consequence of the overall cost structure in CEE countries. That adds up to an important
difference in cost," said Madai.
In CEE, Merck operates primarily in Hungary, the Czech Republic, Poland, the Baltic region, and Russia. The company is seeing
a growing proportion of its total study volunteers coming from CEE.
"A significant downside of doing clinical studies in the region used to be the lengthy wait for approvals by local regulatory
and import agencies, hospitals, and ethics boards. Those time frames have grown substantially shorter over the past several
years and are now close to the EU average. Most CEE countries complete approvals within 60 to 70 days. The speed of patient
recruitment into studies more than compensates for any disadvantage in terms of regulatory approval time," explained Madai.
"But the CEE is definitely not a single, homogenous region," cautioned Madai. "Individual countries have separate heritages,
levels of development, and vocational backgrounds." As a result, growth in trial activity has been highly variable in the
region. Since 2003, for example, Poland has experienced flat growth in the number of FDA regulated principal investigators.
The number of them in Russia, on the other hand, has grown more than 25% during that same period.
"Personnel at smaller country hospitals throughout the region also may have limited knowledge of GCPs," said Madai. Sponsor
companies, including Merck, have yet to attempt much training on GCP in the Balkan countries.
