The number of clinical trials approved in Russia during the first quarter of 2008 showed a slight decline year on year following the market’s strong recovery in the second half of last year from a temporary ban on the export of biological samples.

The Federal Agency for Health Care and Social Development (Roszdravnadzor/RZN) cleared 130 new trials during the latest quarter, four less than in the opening quarter of 2007.

The figure also compared very unfavourably with the 174 trials approved by the RZN during the fourth quarter of 2007, However, that exceptional tally reflected a rebound in the Russian market following the ban imposed by the Russian Federal Customs Service in late May 2007, which was blamed for a 13% fall in trial approvals during the second quarter of last year.

International multicentre studies still account for the majority of new trials signed off by the RZN – 62% in Q1 2008, the same proportion as in the year-before period. At the same time, the number of approved international trials dropped from 83 to 80, notes the latest report from Moscow-based contract research organisation (CRO) Synergy Research Group.

Foreign sponsors started 88 trials during the report period, 68% of the total. The most prolific of these sponsors was GlaxoSmithKline, which secured approval for 12 trials in the first quarter of 2008. Its closest multinational contenders were Pfizer and Novartis with six trials apiece.

Russian sponsors launched 42 studies in Q1 2008, led by Pharmstandard with a total of four trials. Russia was the leading single-country source of trials approved during the quarter, followed by the US (33), the UK (15), Switzerland (11) and Germany (10).

There was also a substantial decline during the latest quarter in the number of patients scheduled to be enrolled in newly approved clinical trials, Synergy Research pointed out. The recruitment target for newly approved trials was 9,358 in total compared with 14,894 in Q1 2007.