The biggest country in the world, in 2018 Russia remains to be one of the top destinations for clinical trials globally. With a 144 million population and growing economy, Russia is within top 10 pharmaceutical markets. Over 60% of new drugs approved in Europe in 2017 were studied in international trials involving Russia.
High recruitment rates, low costs, modern infrastructure and improving regulatory climate make Russia a great choice for companies seeking to save without exposing themselves to the challenges common to other emerging regions.
Russian population is highly urbanized and mostly concentrated in big cities, such as Moscow and St. Petersburg metropolitan areas of 16 and 7 millions, correspondingly. Combined with state-run centralized medical system, this allows to enroll patients in major city hospitals and highly specialized medical institutions without having to open many sites. Communication and transportation systems are efficient and patients will be willing to travel to the sites and stay in touch with their doctors in course of the study. Migration is very low compared to US or Western Europe, and very few patients are lost to follow-up, even most extended ones.
Investigators are highly qualified, well equipped and familiar with international therapeutic and clinical research standards and practices. GCP is fully incorporated in Russian legislation. With the ongoing shift towards insurance-based medicine the level of documentation work has improved greatly over the past decades. Russia is frequently inspected by the US and European authorities and the quality of the data is regarded as exceptional. The number of inspections by local clinical trials and drugs safety Authority (a part of ICMRA since 2016) is vast and increasing, and most of them result with NAI. GCT has successful experience with FDA and Local Authority inspections.
In terms of the approval process, the timelines are constantly shifting down as most of the studies get an approval in under two months. We obtain approvals for 99% of our submissions in Russia.
With the growth of clinical trials by local Russian pharmaceutical companies, the infrastructure for clinical trials in Russia has seen a dramatic improvement over the past years. Patients are aware of clinical trials as a phenomenon, and are eager to participate.
Key local authority: Ministry of Healthcare
Image credit: Moscow Kremlin © A.Savin, WikiCommons