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Russia's trial approval rate drops for second consecutive quarter; more resources needed says Synergy

By Gareth Macdonald , 17-Aug-2011
Last updated the 22-Aug-2011 at 10:09 GMT

Russian authorities need to dedicate more resources to reviewing trial applications ahead of new site accreditation rules due to come into effect later this year according to report on the country’s contract research sector.

The study, by Moscow CRO Synergy Research Group, revealed that only 114 clinical studies were given the green light by the Russian Ministry of Health and Social Development (MoH) in the three months to June 30, down 36 per cent on the number approved in comparable period last year.

Synergy CEO Igor Stevanov told Outsourcing-pharma.com the decline was biggest among local CROs which had only 14 trials approved in the period, down from 64 in the second quarter last year. The number of bioequivalence (BE) studies was also lower at nine compared with 33 in Q2 2010.

Stevanov said part of the reason for the falling approval rate, which continues the pattern seen in Synergy’s Q1 report , is that the MoH has dedicated only ‘limited resources’ to clinical trial reviews since taking over responsibility for the process from the Roszdravnadzor last year.

He added, however, that while expanding the MoH’s team and making legal revisions that expedite the review process would help, the problem of the falling approval rate is likely to continue for some time to come.

I think it will not be fixed until 2012, since there's another upcoming bottleneck likely to happen in September. The thing is that all investigative sites in Russia [about 1,200] need to update their accreditation from MoH by September 1 2011, otherwise they will not be entitled to conduct clinical trials. Currently just over 150 sites are approved by MoH.”

Multi-national trials up

However, despite these issues, Stevanov is optimistic about the Russian contract research sector, particularly the country’s role as a location for multinational multicentre clinical trials more of which were approved in Q2 than in the equivalent period last year, 91 vs 77.

He suggested that increase was because drug firms like GlaxoSmithKline (GSK), Roche, Eli Lilly, Boehringer Ingelheim and Merck & Co, the top five most active international sponsors in the country in the period, recognise the importance of the Russian drug market.

They need Russian data if they want to sell their drugs in Russia, there no other way according to the new law,” Stevanov suggested, adding that the relatively high patient recruitment rates that can be achieved in the country are also a factor.

In addition, he predicted that the Russian government’s Pharma 20-20 plan, unveiled earlier this year as a way of boosting the number of drugs tested and manufactured in the country, would also impact the contract research sector.

The number of BA/BE studies by Russian companies will definitely grow, and I also hope that NME will start to appear among testing drugs, since Rusnano and Skolkovo financial power is being involved.”

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