The Current Climate of Clinical Trials in Russia and Ukraine | Page 15

Benefits of Clinical Trials in Russia
and Ukraine
Large pools of patients in urban areas and specialized
centers provide recruitment potential, often of patients
who are treatment naïve. The disease patterns, such
as those of some endemic diseases, provide the
opportunity to access patients that are not present
elsewhere. Given the high cost of specialized medical
care and most medications, a clinical trial is an
affordable alternative to receive the care needed.
Because of this patient availability, good compliance
and motivated patients and doctors, the recruitment
period is comparatively short.
The term Russian Troika has been used
to describe the three attributes of
clinical trials in Russia:26
HIGH PATIENT RECRUITMENT
HIGH-QUALITY DATA
REDUCED COST OF RUNNING A TRIAL
COMPARED WITH US OR EU

Clinical trials for rare indications can benefit from
registries of patients with rare diseases maintained by
some specialized centers; for example, a registry for
acromegaly in Russia has a list of approximately 700
patients. Federal registries are also available for patients
with specific diseases.9
In addition, with the efforts to harmonize the
regulations for Russia, Belorussia, Kazakhstan,
Armenia and Kyrgyzstan, which should be completed
in 2016, additional populations will become available.
Although rapid recruitment could be construed as
a threat to quality, the cooperation between doctors
and sponsors and between patients and investigators
ensures good quality data. Extensive experience
in clinical trials is present in the research centers
and universities supported by the government-led
initiatives that support research, and the quality of the
trials data has also been confirmed by almost 100 US
FDA inspections in Russia since 1995.26
While the cost of clinical trials has been described as
lower than in other countries, this can depend on the
therapeutic area, the product under investigation and
the currency situation. However, the costs are typically
at least comparative.

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Large pools of patients in
urban areas and specialized
centers provide recruitment
potential, often of patients who
are treatment naïve.

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