Novakovskiy_edit.qxp 4/6/07 3:39 pm Page 22
Optimising eClinical
Figure 1: Companies Involved in Clinical Trials in Russia
80
60
55%
40
46%
42%
35%
37%
29%
20 25%
21%
10%
0
2000-2003 2004 2005
Local pharmaceutical and biotechnology companies
International pharmaceutical and biotechnology companies
Contract research organisations
Source: www.regmed.ru
and since 2000 has been supporting efforts in Russia to conduct trials number of clinical trials approved between 2003 and 2004, which can be
to world-quality standards, thus paving the way for today’s sponsors attributed to the increase in the number of mergers in the worldwide
from the research-based pharmaceutical industry to place their studies healthcare sector at that time. Post-integration companies focus on
in the region with confidence. FDA audit data suggest that data internal reorganisation, thus we see an increase in the number of trials in
quality in Russia is at least as good as that from other regions around 2005 as these new entities resume normal operations.
the world (see Table 2).
Driving the Growth in Clinical Trials
These days more than 100 foreign pharmaceutical companies are When clinical trials first came to Russia, foreign pharmaceutical
accredited in Russia, mostly located in Moscow. The international companies had no representatives in the country; therefore, they started
work through local groups of researchers. The first group was based in
the Research Institute of Cardiology in St Petersburg and the first CROs
A CRO is able to pay much higher
began to appear around 1990.
wages than government-owned
There are currently around 10 domestic CROs in Russia, with Congenix
medical institutions, and can
one of the most advanced. The main difference between Russian CROs
and CROs in other countries is that in Russia all clinical research associates
therefore select the best, most
(CRAs) are medical doctors. A CRO is able to pay much higher wages than
highly experienced professionals.
government-owned medical institutions, and can therefore select the
best, most highly experienced professionals. Many CRAs speak fluent
English, which helps a great deal in communication between investigators
companies that do not have representation in Russia still conduct clinical and sponsors in terms of monitoring, reporting and so on. Russian CRAs
trials there through third-party organisations. Many major contract are trained in GCP, and many are also members of international
research organisations (CROs) have opened offices there, and there are professional organisations such as the Drug Information Association (DIA)
several local CROs, including Congenix, LLC (see Figure 1). and the Association of Clinical Research Professionals (ACRP).
The number of clinical trials conducted in Russia has increased The role that these groups played in shaping the clinical research market
considerably over the past 10 years, and this trend continues with on in Russia cannot be underestimated. They translated GCP guidelines and
average close to 100 new trials being approved every year. Interestingly, introduced them to regulators, medical professionals and the
the number of trials outsourced to specialised CROs is also growing, community; they implemented the most reliable communication
allowing international companies to benefit from local resources, technologies; they established data management systems; and they
intelligence and expertise (see Figure 2). There was a slight decline in the implemented modern methods of statistical analysis. In short, they
22 DATA MANAGEMENT IN PHARMACEUTICAL RESEARCH & DEVELOPMENT
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