Decline in Russian trial approvals slows in Q3

07-Nov-2011 - Last updated on 27-Nov-2023 at 11:15 GMT

New data suggests the Russian MoH is getting faster at reviewing and approving clinical trials.

According to Synergy Research’s latest quarterly report the Russian Ministry of Health and Social Development of the Russian Federation (MoH) OKed 132 clinical trials in the third quarter, two fewer than were given the green light in the equivalent period in 2010.

This total, while still lower than Q3 last year, is the most trials the MoH has approved in any quarter this year. It is also much closer to the number cleared in the comparable period in 2010 by the Roszdravnadvor, the organisation that was previously responsible for overseeing clinical research.

The figures will help to reassure those in Russia’s expanding contract research sector who suggested that the slowdown in approvals seen earlier this year was an indication the MoH had not devoted enough resources to trial reviews.

The report is the second piece of good news for the MoH in the last few months.

In September, the organisation revealed that it had completed its review of more than 600 clinical trial sites significantly easing concerns that it would not be able to cope with the 1,200 or so sites that urgently required reaccreditiation at the time.

International activity

The proportion of clinical trial approvals granted to international pharmaceutical manufacturers increased to 67 per cent from 57 per cent, with number for studies sponsored by local drugmakers dropping from 58 in Q3 2010 to 44.

Additionally, the number of multinational, multi-centre trials increased to 84, up 40 per cent on Q3 last year, while the number of ‘local’ Russia-only and bioequivalence studies was both down, falling 21 per cent to 33 and 53 per cent to 15, respectively.

While it is hard to draw any firm conclusions without more detailed data on the MoH's criteria, the higher proportion of approvals granted to trials sponsored by international firms does fit with the trend that has seen international drugmakers increase their efforts in the Russian market.

Speaking with Outsourcing-pharma.com in August Synergy CEO Igor Stevanov said international firms like GlaxoSmithKline (GSK), Roche, Eli Lilly, BoehringerIngelheim and Merck & Co - all of which sponsor studies in the country - recognise the importance of conducting trials in Russia, adding that: “They need Russian data if they want to sell drugs in Russia."