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Dispelling the Myths Surrounding Clinical Trial Supplies in Russia

The Clinical Trial Market and Regulatory Requirements in Russia

Large-scale clinical trials have been conducted in Russia since 1989. However, at that time, regulators and the medical research community were largely unaware of good clinical practice (GCP) rules. The Clinical Pharmacological Research Institute (CPR) carried out the first translation of the GCP guidelines in 1989. Several years later in 1999, the official text of ICH GCP in Russian was published by Brookwood Medical Publications.

That same year the Russian-language version of GCP became a part of national regulations on clinical research. At present, Russia has an established system of national regulations for drug development and clinical research, with clinical trials being approved in a way similar to that in the West. The number of clinical trials conducted in Russia has increased considerably over the past 10 years. On average, close to 100 new trials are approved in Russia every year. Many large international pharmaceutical companies and major CROs have opened offices in Russia. In addition, there are several local CROs.

Russia continues to be a very attractive place to conduct clinical trials due to the following factors:

ICH GCP is now an integral part of drug legislation in most
Eastern European countries. In Russia, National Standard
OST 42-511-99 is a close translation of ICH GCP. The Russian
National Ethics Committee and the local ethics committees
are constituted according to ICH GCP regulations. They provide
ethical approval for clinical research in Russia in compliance with
international ethical standards. The investigative centres in Russia
must obtain a licence from the Ministry of Health in order to be
allowed to conduct clinical trials.


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By Elena Storozhuk, MD, MS, Director of Business Development, and Sergei Varshavsky, MD, PhD, Chairman and CEO of DW Coordinating Center, USA Elena Storozhuk, MD, MS is the Director of Business Development at DW Coordinating Center (DWCC), a global CRO, conducting multinational clinical trials in Russia and Eastern Europe, headquartered in Los Altos, California. Elena received her medical training at the Semashko Medical School in Moscow. She obtained her Masters Degree in Clinical Pharmacology at Ohio State University and held different positions in the clinical department at Neoprobe Corporation. In her previous position with ICON Clinical Research, Elena was involved in global project management, medical monitoring and site management of large Phase III multi-centre multinational trials, safety surveillance and medical writing. Her clinical research experience includes the following therapeutic areas: infectious diseases, oncology, bone marrow transplantation, cardiovascular diseases and gastrointestinal disorders.
Sergei Varshavsky, MD, PhD is Chairman and CEO of DW Coordinating Center. Sergei received his medical training at the I. P. Pavlov First Medical School and Postgraduate Medical School in St Petersburg, Russia. He began his career as a Researcher at the Research Institute of Cardiology in St Petersburg, specialising in thrombolic therapy in acute miocardial infarction. Over the past 12 years, Sergei has been directly involved in all clinical trials conducted by DWCC. He was a National Coordinator for large multi-centre studies. Sergei has contributed to more than 30 publications in international scientific journals and was the first clinician to conduct a Quality of Life study in Russia. Sergei is also Head and Founder of Clinical Research Institute (CPR) in St Petersburg.

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Elena Storozhuk
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Sergei Varshavsky
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