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Optimising eClinical
Clinical Trials Abroad – ‘Back in the USSR’
a report by
Vladimir V Novakovskiy, MD, PhD
Vice President of Regulatory Affairs and Quality Assurance, Congenix LLC
The drug development services industry constitutes a significant and Large-scale clinical trials have been conducted in Russia since 1989.
growing portion of all pharmaceutical and biotechnology drug However, back then when interest first arose, regulators and the medical
development activity. Sponsor companies in the life sciences industry research community were largely unaware of good clinical practice
are continually striving for more efficient and cheaper ways to bring (GCP) and clinical trials were not governed by any regulations – anyone
compounds to market. Conducting work in countries outside the US could do anything. There was the constitution of the USSR, which
and Western Europe is one strategy to help reduce costs and is protected the rights of patients, but that was it; ethics committees had
becoming increasingly common, particularly for clinical trials. Here are yet to be established. Things have changed drastically, and nowadays
some illustrative facts: there is a system of national regulations for drug development and
clinical research, with clinical trials being approved in a similar way to in
• the total cost of bringing a new product to market is estimated to be the West.
US$800–1,000 million;
In 1999, the official text of the International Conference on
• only one in five commercial products will generate a profit; Harmonisation (ICH) GCP standards was published in Russian. In the
• the number of US Food and Drug and Drug Administration (FDA)-
sanctioned ‘offshore’ trials increased from 1,000 in 1991 to 7,000 in
2000; and Russia has a large number of big,
highly specialised hospitals that
• the percentage of new drug application (NDA) submissions to the FDA
that include data generated from offshore trials has increased
could have been specifically designed
dramatically over the last five years.
for clinical research.
Of the various locations, Russia and ‘Russian-speaking’ countries are
particularly attractive to the sponsor companies. This is because of
Russia’s clinical trials authorisation (CTA) system and its healthcare same year, the Russian-language version of the GCP standards – National
system, including the available investigators and subject population. This Standard OST 42-511-99, a close translation of ICH GCP – became a part
last factor is perhaps the most important: the enormous enrolment of national regulations on clinical research.
potential offers a solution to the competition for clinical trial patients in
North America and Western Europe. Nowadays, the legal basis to conduct clinical trials in Russia is governed
by the 1998 Federal Law on Drugs. The regulatory basis for conducting
Furthermore, Russia has a large number of big, highly specialised clinical trials in Russia is the 2005 National Standard of the Russian
hospitals that could have been specifically designed for clinical research. Federation 52379-2005 Good Clinical Practice, a translation of the GCP
These medical centres may have modest interiors, but this does not E6 guideline. The Russian Ministry of Health and Social Development
preclude their clinicians from carrying out quality work. also regulates the process by means of various Orders and Instructions,
all of which have been developed in correspondence with the law and
Vladimir Novakovskiy, MD, PhD, is Vice President of
national standards.
Regulatory Affairs and Quality Assurance at Congenix,
a contract research organisation (CRO) specialising in
The Federal Service for Supervision in the Sphere of Health Care and
conducting clinical trials in Russia and countries of the
Commonwealth of Independent States (CIS). Congenix Social Development has direct control in the field. This regulatory
provides comprehensive solutions for the pharmaceutical
body grants the CTA and reports to the Russian Ministry of Health and
and life sciences industries using its own experience
combined with the advantages of ‘Russian-speaking’
Social Development.
countries. In his 10 years’ working in clinical research,
Dr Novakovskiy has served in a variety of positions in
Obtaining a CTA requires parallel favourable decisions from the federal
CROs, starting with CRA at the Moscow office of Quintiles.
Dr Novakovskiy holds a medical degree from St Petersburg
Ethics Committee and the Scientific Centre for the Evaluation of the
Medical University. He also has a PhD in medicine,
Products for Medicinal Use (a federal state institution, or FSI). In
specialising in recombinant cytokines.
general, it does not take more than 60 days to obtain a CTA after
submission, including import and export licences.
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