Russia sees 13% fall in new trial approvals

The number of new clinical trials approved by Russia’s Federal Surveillance Service for Healthcare and Social Development (Roszdravnadzor/RZN) during the first quarter of 2009 fell by 13.1% year on year to 113.

According to the latest report from Moscow-based contract research organisation (CRO) Synergy Research Group, the main cause of the decline was 36.6% drop in the number of Phase II trials cleared by the RZN, from 41 to 26.

In fact, the only stage of clinical development to show any improvement was Phase III trials – 9.3% ahead of Q1 2008 with 59 trials approved in total. The relatively low volume of Phase I trials was down by 42.9% from seven to four, while there were 25% fewer Phase IV studies (nine).

International multicentre studies still make up the bulk (63.7%) of new clinical trials started in Russia, although in volume terms they were 10.0% below the first quarter of 2008, falling to 72 trials in total. The proportion of multicentre to overall trials was slightly higher; it was 61.5% in Q1 2008.

The RZN registered 27 local clinical trials in Russia during the latest quarter, 27.0% fewer year on year, and 14 bioequivalence studies (+7.7%).

While on an individual country basis Russian sponsors initiated the most clinical trials (31) in Q1, followed by sponsors from the US (20) and Germany (12), multinational companies overall were responsible for 88 or 77.9% of the new trial approvals during the report period, compared with 82 or 63.1% one year earlier.

The leading international sponsors in the first quarter of 2009 were Boehringer Ingelheim and Novartis with seven trials approved apiece, although Boehringer Ingelheim’s trials were larger overall: 695 patients at 63 sites versus 397 patients at 54 sites for Novartis. The third most prolific international sponsor was Pfizer, with six trials started in Russia at 16 sites.