Russia has been boosting its credentials as a location for international clinical trials, with 70% of new drugs registered in Europe in 2015 tested in phase II-III clinical trials in the country. With its high recruitment rates, low costs, fast-evolving infrastructure and improving regulatory structure, combined with the growing financial pressure on international pharmaceutical and biotechnology companies, it’s no surprise the country’s popularity has increased. But is its growth trajectory any different from other markets and, given the unique challenges that face companies conducting studies in Russia, what can we expect from its future?
The number of clinical trials given the go-ahead in Russia increased by 13% in the third quarter of 2015, with the Ministry of Health of the Russian Federation approving the start of 203 new clinical trials of all types in that quarter alone and the number of phase III trials rising 14% to 90, according to data from contract research organisation (CRO) Synergy.
Moreover, according to CRO Smooth Drug Development, 70% of new drugs registered in Europe in 2015 were tested in phase II-III clinical trials in the country, and Russia is particularly increasing its focus on early phase trials. Currently, the company says, phase I and II trials account for about a quarter of all clinical trials in Russia.
There are a host of factors that underlie Russia’s attractiveness as a location for all types of clinical trials – not least low costs.
“International pharmaceutical and biotechnology companies are facing constant margin pressure. Developed markets show limited market growth and restricted patient access,” explains Julia Sardaryan, corporate development director and managing partner at Smooth Drug Development, the first ISO 9001:2008 certified CRO in Russia.
“Competitors are entering developing nations because competitive intensity is increasing. Thus, many companies are looking for alternative markets like Russia.”
According to Synergy CEO Igor Stefanov, lower investigator salaries and local CRO rates allow savings of up to 78% in direct costs when compared to the US or the EU. “This means that a single 460-patient phase II oncology study could save almost $27m if conducted in Russia,” he stresses.
Other advantages of conducting clinical trials in Russia include short enrolment periods (due to Russia’s centralised healthcare system, it isn’t necessary to open many sites to enrol patients; they can be enrolled at big regional and city hospitals), high recruitment rates (the market is currently under-saturated and investigators are motivated to enrol patients not only because they receive additional payments but also because they get access to new drugs for their patients), an improving regulatory framework, which is becoming more transparent and less arduous for international players (for example, sponsors no longer have to carry out pre-clinical studies and draw up a registration dossier before clinical trials can take place), and rapidly developing clinical trial infrastructure, particularly for early phase trials.
“A number of specialised phase I facilities and PK laboratories were built within the last five years,” Sardaryan notes. “One of the examples is the first dedicated phase I unit BioEq created with the assistance of the Russian Venture Company.”
For Sardaryan, there are several advantages that Russia can offer specifically for early phase studies. “[The country has] good infrastructure, which includes experienced clinical trials vendors specialising in early phase research and state-of-the-art hospital-based phase I sites, which know how to deal with early phase study challenges,” she notes, adding that these challenges include cohort management, complex study logistics, ethical challenges and timely data entry.
“Russia can [also] offer a group of scientifically oriented principal investigators belonging to the medical elite, who can correctly deliver information to patients regarding the benefits and risks of early phase trials,” she continues.
“Moreover, Russia offers access to patients, who are eager to participate in clinical trials in order to get access to new therapies, [as well as] established processes and timelines for regulatory approval. The regulatory approval process takes just 35 working days (parallel review by the Health Authority and Central Ethics Committee), which is absolutely comparable with European timelines for clinical trials.”
Finally, Stefanov is keen to add that, contrary to some opinions, Russia’s IP laws are up to international standards.
“Many people believe that Russia has poor protection for IP; in reality, Russia has steadily strengthened its IP laws,” he explains. “According to an Ernst & Young report, in 2012, after 18 years of negotiations, Russia became the 156th member of the World Trade Organization (WTO). As part of the WTO accession, Russia has five significant economic commitments (including to) ensure the protection of intellectual property rights.”
Challenges: it’s who you know
There are, however, several challenges for international companies – even those familiar with the market – that wish to carry out clinical trials in Russia, including the necessity to get documents translated, which takes an additional 15-30 days, and drug import and customs clearance, which, according to Sardaryan can also delay studies.
“Both challenges can be overcome if proper vendors are selected and the study performance is planned ahead, though,” she believes, adding that on-time delivery of drugs can be performed by international logistics companies.
Adds Stefanov: “Without assistance from local, Russian experts, many companies make the same mistakes, costing them lost time, poor quality, lost revenue, and lost opportunity.”
A mixed future outlook
Looking to the future, Stefanov and Sardaryan have conflicting opinions. While Sardaryan believes that, regardless of the political situation, more companies will start to view Russia as a potential location for clinical trials, including early phase studies, Stefanov thinks the number of early stage clinical trials will remain the same in the next few years at best, a continuation of the current situation.
“The annual growth of the total number of new studies in Russia (6,02 CAGR) is the same as the worldwide figure (6,03 CAGR) while the number of international studies [has remained] almost the same during the last decade,” he says. “Moreover, Russia’s market for contract research services in 2014 was worth $360m, down from its peak value of $436m in 2012, according to the local experts.”
“Russia as an emerging clinical trial market is a myth. And if the geopolitical situation becomes worse, we expect the twofold decrease in the number of international studies, which means that mostly local pharma companies will conduct early stages.”