The Current Climate of Clinical Trials in Russia and Ukraine | Page 7

Compliance with trial requirements is reportedly
high, given the high level of patient literacy (99.7%
literacy rate in those aged ≥15 years3) and respect for
medical doctors, resulting in a willingness to cooperate
with instructions and complete the trial. Not only
are patients willing to participate, doctors are also
motivated to conduct clinical trials for a number of
reasons, including scientific interest.
The majority of trials are conducted in large cities,
including Moscow, Saint Petersburg, Novosibirsk and
Nizhniy Novgorod, primarily for logistical reasons
(patient concentration, availability of experienced
investigators, less travel).

‘‘

The majority of trials are
conducted in large cities, including
Moscow, Saint Petersburg,
Novosibirsk and
Nizhniy Novgorod.

Regulatory Requirements in Russia
Medications cannot be registered without at least a
Phase III clinical trial conducted in Russia, which can
be a multinational trial, but requires a permit.25
The Ministry of Health (MoH) of the Russian
Federation as well as the Roszdravnadzor approve and
oversee clinical trials. Clinical trial applications are
submitted to the former, which ensures the quality,
safety and efficacy of medicines marketed in Russia.
The latter is the control/pharmacovigilance agency that
performs audits on sites and CROs and receives reports
of adverse events and suspected unexpected serious
adverse reactions (SUSARs) via the website.

The MoH receives the package for clinical trials: the
application and all related documents, including the
fee for the permit, a copy of the contract for
compulsory insurance and the good manufacturing
practice (GMP) requirements, which were introduced
on January 1, 2014.

CLI NI CA L STUDIES CONDUCTED PER
1 , 0 0 0 ,000 PEOPLE IN 2 009
80
70
60
50
40
30
20
10
0
Russia

U SA

Figure 3. Clinical studies conducted per 1,000,000 people in 200924

Canada

Belgium

Poland

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