The Current Climate of Clinical Trials in Russia and Ukraine | Page 13

‘‘

As in Russia, compliance with
trial requirements by participants
is reportedly high, given the high
level of patient literacy (99.8%
literacy rate in those aged ≥15
years5) and respect for
medical doctors,
Clinical Trials
Since 1996, 4,080 applications for international,
multicenter clinical trials have been approved.40 Of the
155 clinical trials approved in the first half of 2014, 108
(69.7%) were multinational, multicenter trials.41
Some of the first international, multicenter trials
conducted in Ukraine were oncology trials, resulting in
considerable experience in this therapeutic area as well
as good results on audits. Now, clinical trials are most
commonly conducted for psychiatric, neurological,
oncological, pulmonary and rheumatic diseases.40
As of June 2015, there were 1,281 active studies
being conducted in Ukraine (clinicaltrials.gov),
primarily Phase II (334, 26.1%) and Phase III trials
(848, 66.2%), with fewer Phase I (30, 2.3%) and Phase
IV (54, 4.2%) trials.
As in Russia, compliance with trial requirements by
participants is reportedly high, given the high level
of patient literacy (99.8% literacy rate in those aged
≥15 years5) and respect for medical doctors, resulting
in a willingness to cooperate with instructions and
complete the trial.
Moreover, because the health-care system has a vertical
referral scheme, the selection of patients for clinical
trials can be centrally coordinated, resulting in faster
recruitment rates.

Regulatory Requirements in Ukraine
The Parliament (also referred to as “Verkhovna Rada”)
and MoH currently regulate the pharmaceutical
market and clinical trials. However, the National
Strategy on Health Reform recommends that these
institutions be re-profiled to create a better regulatory
environment and improve stewardship.35
Pharmaceutical reform is a component of the national
strategy and aims to ensure the availability of safe,
affordable and effective medicines.35 This includes
harmonization of regulations with those of Europe,
as agreed upon by the APRaD, EFPIA and MoH of
Ukraine on March 3, 2015.38
Although with recent focus and drive to achieve these
goals, they have been in place for a number of years
with a number of updated pieces of legislation in 2009,
including the:
• MoH Ukraine Order of 16.02.2009 № 95
Guideline on clinical trials. Medicinal products.
GCP. Guideline 42-7.0:2008 based on ICH
Topic Е6, Note for Guidance on Good Clinical
Practice СРMР/ICH/135/95
• MoH Ukraine Order of 23.09.2009 № 690
‘’About Approval of Procedure for Conducting
Clinical Trials of Medicinal Products and
Expert Evaluation of Materials Pertinent to
Clinical Trials and Model Regulations of the
Ethics Committees” (Registered at the Ministry
of Justice of Ukraine on 29.10.2009 under №
1010/17026 and № 1011/17027) amended by:
» MoH Ukraine Order of 06.05.2012 №304
“On introduction of changes into the
MoH Ukraine Order of 23.09.2009 №690”
(Registered at the Ministry of Justice of
Ukraine on 07.07.2014 under №739/25516)
(hereinafter – the Procedure);
» MoH Ukraine Order of 12.07.2012 № 523
“On introduction of changes into the MoH
Ukraine Order of September 23, 2009 №
690” (Registered at the Ministry of Justice of
Ukraine on 20.07.2012 under №1235/21547
and №1236 /21548)

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