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Irina Petrova, Director of Clinical Operations for OCT Clinical Trials, explores why U.S. companies are turning to Russa after having secured approval for 108 trials there in 2018.
The number of clinical studies conducted across the world has been demonstrating a steady growth. With an estimated value of $44 billion in 2019, the global clinical trials market is expected to show a CAGR of 5.7% by the end of the year. For Russia specifically, which joined the World Health Organization (WHO) international drug control program in 1998, the nation has been actively involved in international clinical trials for about 20 years. While relatively young, the region has been demonstrating a lot of potential and increased significance over the past decade for sponsors looking for new clinical trial options.
According to Russian Ministry of Health Registry of the Approved Clinical Trials, in 2018, out of 654 of new clinical trials approved in Russia, more than 50% (385 trials) were initiated by non-local multinational pharmaceutical companies, with the share of multinational, multicenter trials having increased by 2.1% compared to the previous year. The list of companies with the highest number of trial approvals in 2018 is topped by Novartis and Roche (Switzerland). Pfizer (USA) made a leap from 15th place to 3rd/4th, sharing it with Janssen Pharmaceutica (Belgium). Next on the list are AbbVie Inc. (USA), AstraZeneca (UK), and Merck & Co. (USA).
U.S. sponsors took the lead among the non-Russian companies, having secured approval for 108 trials in Russia in 2018. Meanwhile, European sponsors initiated 223 trials in the country last year, 73 of which were sponsored by the Swiss companies. While Phase III studies traditionally prevail in the overall list, most studies approved in 2018 will run in oncology (114 studies), rheumatology (10%), and neurology (less than 10%).
“The ongoing trend has been taking shape over the past several years, showcasing the growing attractiveness of the area for international sponsors,” says Dmitry Sharov, president, OCT Clinical Trials, a CRO operating in Eastern Europe (the company started more than 30 new studies in 2018, including projects in oncology, gastroenterology, neurology, and ophthalmology). “Considering the obvious advantages of the Eastern European, Russian, and CIS regions, including a solid scientific platform, it is no surprise on how quickly this area has developed the necessary infrastructure and local expertise for running high-quality clinical trials. While the emergence of new firms is inevitable for any developing market, for the past several years we have been witnessing a consistent and necessary trend of tightening the regulatory requirements initiated by local lawmakers. These measures gradually even out the market landscape, form a solid quality platform and the proper code of clinical trials, which results in creating conditions where sponsors are willing to pay for quality.”
Evaluating the structure of the Russian market, it is worth noting that Phase III studies prevail among the foreign-sponsored trials in 2018. Historically, these are not only the largest studies in terms of the number of patients recruited, but also the most costly and time-consuming. At the same time, Russian pharmaceutical companies led the way in number of bioequivalence projects initiated in 2018. Irina Petrova, OCT clinical operations director, attributed this to an import substitution trend, lowered drug prices for taxpayers, and an increase in the number of generics worldwide.
The next step in Russia could be the development of innovative products for the global market, including stem cell therapies, opportunities made possible by the 2018 amendments to Russian legislation in this area. Last year, the government of the Russian Federation approved an action plan for the creation of new high-tech production sites and collective-use centers. According to the decree (No. 337-r), the number of medical organizations accredited to conduct clinical trials of biomedical cell products will increase from five in 2018 to 50 in 2020.
There are several factors driving the attractiveness of Russia as a region for conducting clinical research. It is one of the leading countries in terms of population size and diversity (Russia is the world's ninth-largest country by population, with more than 146 million people). This points to an advantage of fast patient recruitment. According to FDA analytical reports, Russia entered the top 10 and ranked second after the U.S. in terms of the number of patients included in clinical trials.
Russia has a developed network of more than 1,600 R&D and specialized medical centers covering virtually all therapeutic areas. The territorial distribution of these centers covers most of the regions in the country, which also increases the accessibility and proximity to patients. Moreover, as a rule, doctor-patient relationships tend to be quite strong, thus securing good patient retention within sites.
The scientific qualifications of researchers and experience of doctors in Russia allows them to conduct projects of any complexity. According to the UNESCO, Russian medical universities are among the best medical schools in the world. Moreover, inclusion of Russian specialists into the global context and international scientific dialogue and a good command of English by medical specialist are important prerequisites for successful sponsor-CRO-site communication.
As for the technological infrastructure, the local clinical research industry fully corresponds to the advanced global levels. Both CROs and research centers in Russia have been successfully working with eClinical solutions (EDC, ePRO, etc.), including products and services to automate development processes, take advantage of cloud solutions, and access information on a project 24/7.
Despite the high growth rate of the Russian pharmaceutical market in general and the development of state drug supply programs, modern/innovative drug therapy in areas such as cell therapy and orphan diseases remain unavailable for the majority of patients. Inclusion of the latest developments in international clinical research is sometimes the only way to get access to necessary and often expensive treatment. This reality spurs additional motivation for patients to participate in trials, as well as the ability to register participants in large regional hospitals due to the centralized Russian healthcare system.
Another key factor that will determine the future of the Russian market is the establishment of a unified regulatory and economic environment for the circulation of medicines on the territory of the Eurasian Economic Union (EAEU). The decision to create such a market was announced on May 6, 2017. The synergy effect from combining the potential of all the member states, as well as the lowering of non-tariff barriers in mutual trade, can stimulate a steadfast development of the industry. A key breakthrough opportunity for pharmaceutical companies and CROs is the option of unified electronic drug registration within the Union. This results in a full-fledged mechanism, when it is possible to run clinical trials in one of the member states and then apply for marketing authorization in any of the remaining participating countries through a simplified procedure.
Irina Petrova, MD, Director of Clinical Operations, OCT Clinical Trials