Russia's clinical biz showing signs of recovery after biologics ban

By Kirsty Barnes

- Last updated on GMT

Related tags: Cent, Clinical trials, Clinical trial, Russia

Russia's clinical trials industry appears to be making a gradual
recovery from a setback earlier this year when the government
imposed an unexpected ban on biologic exports.

According to new research published by Russian contract research organisation (CRO) Synergy Research Group, the country's Federal Agency for Health Care and Social Development (Roszdravnadzor) issued 141 approvals to conduct new clinical trials during the third quarter. Although this figure is actually only 2 per cent more than in the comparable 2006 quarter, it is a big step forward from the scenario in the second quarter of this year, when Russia experienced a 13 per cent decrease in new trial approvals. Dragging the figures down was a 25 per cent fall in the number of international multi-centre clinical trials being given the green light. "We think this decrease in international business is primarily due to the recent biologics ban,"​ a spokesperson from Synergy told Outsourcing-Pharma.com at the time. At the beginning of June, the Russian Federal Customs Service (FTS) without warning shut down the export from the country of all human medical biological materials, including blood and human tissue. The situation was eventually resolved, with things returning to as they were before the ban was implemented. "For two weeks during the ban there were no official announcements from government officials as to the situation and no one knew what was going on."​ The spokesperson believes that some international companies did not submit or withdrew clinical trial applications in Russia as a result. "If the ban hadn't occurred I think that the number of international trial approvals in the second quarter would have been at least the same as in the first quarter."​ Meanwhile, during the third quarter of this year, foreign sponsors accounted for 69 per cent - a minor decrease - in the total number of studies initiated, with the majority coming from the US (30 per cent), and Germany accounting for 10 per cent and the UK 7 per cent. Bristol Myers Squibb (BMS) was the dominant foreign presence, with seven new studies in 95 sites (out of the 800 in Russia), recruiting 2,033 patients - 14 per cent of the total. However, despite a 57 per cent jump in the number of Phase II trials there was also an 18 per cent decrease in the number of larger Phase III trials and a 12 per cent dip (to 14,431) in the number of patients who are planned for recruiting, compared with the 2006 third quarter. In terms of therapeutic area, oncology saw the most clinical trials activity in Russia, (29 studies in 230 sites and 1,784 patients); followed by cardiovascular disease (18 trials, 220 sites, 4851 patients); and central nervous system (CNS) diseases (15 trials in 84 sites and 1,112 patients).

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