The Current Climate of Clinical Trials in Russia and Ukraine | Page 6

THE RAPEUTIC A R EAS IN CL I NI CAL TRI AL S I NI TI ATE D I N RUSSI A

2014

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Oncology

Oncology

Endocrinology

Pulmonology

Rheumatology

Musculoskeletal

Cardiovascular

Circulatory System

Pulmonology

Neurology

Hematology

Others

Neurology
Infectious Disease
Gastroenterology
Dermatology
Psychiatry
Others
Figure 2. Therapeutic areas in clinical trials initiated in Russia in 201421 and 201523
Others (2014) = Ophthalmology, allergology, gynecology, nephrology, urology, hepatology and others
Others (2015) = Not reported

Clinical Trials in Russia
In 2014, there were 48 local studies with new
innovative molecules, vaccines and bioanalogues
sponsored by Russian pharmaceutical companies. Of
the 750 approvals for clinical trials granted in 2014, 468
(62.4%) were local, and 282 (37.6%) were multinational
clinical trials: 3% Phase I, 20% Phase II, 72% Phase III
and 5% Phase IV.21,22
During the first quarter of 2015, 60 multinational,
multicenter trials being conducted by companies from
21 different countries were approved (40%), with an
observed increase in Phase I and II trials.23 As of June
2015, there were 3,022 active studies being conducted
in the Russian Federation (clinicaltrials.gov), primarily
Phase II (783, 25.9%) and Phase III trials (1,748,
57.8%), with fewer Phase I (126, 4.2%) and Phase IV
(232, 7.7%) trials.
The oncology therapeutic area continues to
represent the majority of clinical trials (Figure 2),
and eight therapeutic areas (oncology, pulmonology,
musculoskeletal, circulatory system, neurology and
others) accounted for 74% of the new trials initiated
in 2015.23

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Although there has been an increase in the proportion
of patients recruited from the Commonwealth of
Independent States (CIS) countries (from <1% in
2005 to 7.5% in 2011), the potential trial population
remains comparatively unsaturated. In 2009, there
were only 2.74 trials conducted for every 1 million
people (Figure 3).24
Combined with the relative difficulty in accessing
affordable, high-quality care, a number of patients
are often i