Russia’s clinical trials market is finding its feet again after suffering an unexpected blow earlier in the year from a temporary ban on the export of biological samples from the country.

The action taken by the Russian Federal Customs Service in late May was blamed for a 13% fall in the number of clinical trial permits issued by the country’s Federal Agency for Health Care and Social Development (Roszdravnadzor) during the second quarter of 2007. A 25% decline in approvals for international multicentre trials testified to the impact of the ban, which lasted for nearly two weeks and included clinical trial samples.

In the latest quarter, Roszdravnadzor granted a total of 141 permits for new clinical trials, 2.2% more than in the third quarter of 2006 (138 permits), according to data from the Moscow-based contract research organisation (CRO) Synergy Research Group. Significantly, the number of approvals for international multicentre trials was stable at 91. A total of 32 permits were issued for local clinical trials, again the same as last year, while the number of approved bioequivalence studies increased by 20% from 15 to 18.

Russian sponsors accounted for 44 or 31% of the 142 trials initiated in Russia during the third quarter of 2007, with international sponsors making up the remaining 69% (98 trials), Synergy Research noted. While the Russian share has grown slightly since last year’s quarter (total 138 trials initiated, 40 Russian-sponsored), it is much smaller in terms of the number of investigator sites involved and patients recruited, the CRO pointed out.

US biggest international sponsor
Among the international sponsors, the US was most prominent with 30% of trials initiated during the quarter (Bristol-Myers Squibb was the most active company), followed by Germany (10%), the UK (7%) and then France, Switzerland and Japan (all 3%).

There was one significant change in the clinical trial profile compared with the third quarter of 2006. In the latest quarter, the number of Phase III trials started in Russia dropped sharply by 17.6% to 61, while the number of Phase II studies jumped by 57.1% to 44. Five Phase I trials were launched, compared with four in Q3 2006, and nine Phase IV post-marketing studies, down from 16 a year previously.