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Clinical Trials Abroad – ‘Back in the USSR’
Table 1: Medical Resources in Selected
patient enrolment continues to be so strong.
Eastern European Countries
Many patients in Russia require specific treatments that are usually
Country Major Cities Physicians Medical Hospital Beds
beyond their reach. Participation in a clinical trial is a good opportunity
per 1,000 Universities per 1,000
for them to receive appropriate long-term treatment because it offers
Inhabitants Inhabitants
Czech Republic 1 3.4 5 8.6
free access to the best medical facilities, the best diagnostic methods,
Hungary 1 3.6 4 8.4
the best physicians and, potentially, the best medications.
Latvia 0 3.2 2 8.7
Lithuania 0 3.8 2 9.2
Typically, the treatment provided in clinical research is better than the
Russia 13 (9) 4.2 55 13.1
standard of care available through the national health services. The
(European part)
fact that trial protocol often calls for complete physical assessments
Slovak Republic 0 3.2 3 8
and personal interaction with the investigator may in itself be an
Ukraine 5 4.6 18 10.4
incentive to join a trial. Combined with the additional lure of Western
Source: The Informer newsletter, June 2003, Imform GmbH.
medicines and therapies, it is easy to see why the prospective patients
are excited to participate.
The Russian Medical System
Russia ranks highly among other Eastern European countries on the The only requirement of the patients is to be compliant, which they
availability of basic medical resources for conducting clinical trials (see consider more than acceptable. The high general level of education with
Table 1). no illiteracy means that most people understand the nature of research
and the need to follow treatment regimens. In addition, Russian people
At present, most clinical trial work is conducted in Moscow and
St Petersburg owing to their better infrastructures, larger populations
and the presence of major research centres in these two cities; well-
equipped academic sites located to the east – from the Ural Mountains
in Siberia to the Far East, which is rich in natural gas and oil resources –
Recruitment rate is fast in Russia: on
remain largely underused.
average 2–4 months ahead of sites in
more developed parts of the world.
The ‘Soviet’-structured centralised healthcare system in Russia and the
countries of the former USSR consists of large medical institutions, many
of which specialise in different therapeutic areas. These institutions, both
general and specific, have large patient pools from which to draw,
making enrolment in clinical trials very easy for the patient and rapid for exhibit a greater respect for authority compared with those in the West
the sponsor. and have a more settled way of life. This all leads to higher acceptance
rates, more disciplined patients, increased compliance with physician
Despite the fact that many medical procedures that in the West might be instructions, low drop-out rates and high follow-up rates.
performed in an outpatient setting require a stay in hospital in Russia, these
additional hospital costs do not add significantly to the trial expenses. Data Quality
Moreover, this additional level of attention is helpful in informing the Despite rumours and existing prejudice, Russia remains a solid and
subjects of their obligations and providing the opportunity to closely reliable arena for conducting clinical trials. Cases of fraud in general
monitor and instruct them early on, thus helping to facilitate compliance. have been found to be much less frequent than in the US. In addition,
the European Forum for GCP (EFGCP) supports initiatives for
The Russian People developing better conditions for clinical trials in and around Europe,
Russia is a country with access to experienced, motivated and compliant
Table 2: Summary of FDA Inspections Performed in Eastern
investigators, for several reasons. First, taking part in a global project
European Countries between 1 January 1994 and 31 March 2002
gives them an opportunity to interact, directly or indirectly, with the
international medical community from which they were almost entirely Country Number of
excluded during the Soviet era. Second, Russian clinicians are
Inspections Observations
scientifically curious; the pioneering essence of a new drug always
NAI VAI OAI
presents an additional incentive for them. Third, most investigators are
Czech Republic 2 1 3 0
Croatia 2 0 4 0
eager to become familiar with new quality standards and
Hungary 6 2 8 0
methodological approaches. This is why the GCP concept is normally
Poland 5 4 1 0
readily accepted by clinicians, even those with no prior practical
Romania 1 1 0 0
experience with the guidelines. Russia 6 4 7 0
Slovenia 1 1 0 0
Recruitment rate is fast in Russia: on average 2–4 months ahead of
Total 23 13 23 0
sites in more developed parts of the world. Patients in Russia are both
NAI = no action indicated; VAI = voluntary action indicated (objectionable conditions found,
but justifying only local measures and not any further regulatory action; any correction is left
eager to participate and extremely compliant. Given the overall
to the investigator to take voluntarily); OAI = official action indicated.
healthcare situation in Russia, it is not difficult to understand why
Source: www.fda.gov
DATA MANAGEMENT IN PHARMACEUTICAL RESEARCH & DEVELOPMENT 21
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