The Current Climate of Clinical Trials in Russia and Ukraine | Page 16

Potential Concerns With Conducting Clinical
Trials in Russia and Ukraine
Recent reports have highlighted some concerns with
the health-care system overall and the conduct of
clinical trials in Russia9,44 and Ukraine.45
On the 2014 Corruption Perception Index, the Russian
Federation scored a 27 and Ukraine scored a 26 on the
100-point scale, with 100 indicating no corruption.46
However, recent laws in Russia, including the federal
law for public health protection enacted in November
2011,47 are actively addressing this issue, and the
elimination of corruption in clinical trials and drug
registration has become a priority for recent and
current political officials.44 These laws outline specific
limitations regarding acceptance of money or gifts
from pharmaceutical companies by medical workers
and executives, the need for truthful and full disclosure
of the medication to patients and the declaration
of conflicts of interest. As a result, there are more
transparent processes and faster, more
stringent timelines.
Moreover, the local Clinipace experience is that
corruption does not occur in the conduct of clinical
trials in either country, and recent laws in Russia
have restricted access by CROs and/or sponsors to
the government officials reviewing and approving
clinical trial documents.44 In Ukraine, in addition to
recent government efforts to increase transparency
and reduce “below-the-table” dealings, the APRaD
has been actively involved in the regulatory reforms in
Ukraine. It is a non-for-profit and non-governmental
organization and member of the EFPIA that is
committed to research and development, quality
manufacturing and distribution of innovative
medicines,48 and, with the Association of International
Pharmaceutical Manufacturers (AIPMUkraine) in
Ukraine, it has launched initiatives regarding the
disclosure of payment and transfer of property by
pharmaceutical companies to health professionals. In
2015, these organizations began to collect information
that will be made available in 2016.49 Therefore,
increased transparency regarding these relationships
is expected.

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Sites that are well equipped
or are suitably equipped for a
specific trial can be identified
by knowledgeable local CROs.

In addition, concerns exist regarding potentially
limited English language skills and access to
international peer-reviewed scientific journals by
medical doctors.9 While this is true for some