Number of trials registered with Russia’s RZN falls 17% in Q2

By Gareth Macdonald

- Last updated on GMT

Related tags: Clinical trial, Russia

The number of registered clinical trials in Russia slipped in Q2, with the country attracting fewer international sponsors and regulatory inspections than in pervious years.

The RosZdravNadzor (RZN), the body that regulates clinical research in Russia registered 129 trials in the three months to June 31, down 17 per cent on last year, according to new research by Moscow CRO Synergy Research Group (SynGR).

The decline was felt across the board with the number of Phase I, II, III studies falling 12 per cent, 27 per cent and 23 per cent respectively.

Despite the drop in RZN registered Phase I- III clinical studies, Igor Stefanov, SynGR’s general manager, was upbeat about the state of the market, particularly in terms of post-market trials.

He told Outsourcing-pharma that: “We do not think there's a decrease in the overall number ofstudies. The thing is that not all Phase IV studies in Russia are registered by Roszdravnadzor, this is optional."

Stefanov went on to say that the global downturn has seen pharma sponsors refocus their research efforts towards marketing and predicted “further growth in the number of Phase IV trials, regardless of the[number of]real R&D Phase I-III studies​.”

Although lower pharma industry R&D spending has undoubtedly had an impact on clinical research worldwide, the research suggests that the downturn has hit Russia harder than other countries.

For example, a recent Business Insights​ report revealed that in India 895 trials were initiated over roughly the same period covered by the SynGR study, which is a significant increase on the 150 that were underway in India by June 2008.

Additionally, while the Russian sector grew dramatically in recent years thanks to demand for cheaper trials and treatment naive patients, 2009 has increasingly seen Latin America as well as other countries in eastern Europe like Poland and the Czech Republic emerge the hot destinations.

Patient recruitment up 4 per cent

SynGR’s survey did reveal some positives for the Russiantrial industry, with patient participation levels remained relatively stable, climbing around 4 per cent on the same quarter last year to 12,388.

Furthermore, the country was still able to attract some major international players with Swiss giant Novartis sponsoring 11 clinical trials in the second quarter. Pfizer, Bristol-Myers Squibb and Eli Lilly also sponsored trials during the period.

Local pharmaceutical firms OAO Valenta Pharmaceutica, OAO Biokhimik, OOO Lans-Pharm, ZAO Obolenskoe and ZAO Biocad were the next most active group of trial sponsors in Q2.

The Synergy full report can be accessed here​.

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