Russia sees slight dip in clinical trial approvals in Q1 2015

By Zachary Brennan

- Last updated on GMT

Russia sees slight dip in clinical trial approvals in Q1 2015

Related tags Clinical trials Clinical trial Contract research organization

The Ministry of Health of the Russian Federation approved 151 total clinical studies in Q1 of 2015, which is 11% less than the same quarter last year, though by comparison, it’s still 10 times more than India has approved in the same amount of time. 

For Russia, the total number of studies was dominated by multinational, multi-center clinical trials (MMCT), which amounted to 60 trials -- the same as in Q1 2014, according to Russia-based Synergy Research Group. The number of bioequivalence studies decreased from 62 studies in Q1 2014 to 47 in Q1 2015, while the number of local clinical trials slightly declined from 47 in Q1 2014 to 44 clinical trials in Q1 2015.

Despite the slight decrease, Igor Stefanov, CEO of Synergy, told Outsourcing-Pharma.com, sounded positive on the role Russia plays in helping sponsors conduct trials. He also said that CROs (contract research organizations) continue to play a major role in running studies in Russia.

It’s quite a long success story of CRO growth since the 1990s. Today, about 60% of trials in Russia are conducted by CROs on behalf of sponsors​,” Stefanov said.

In terms of sponsors, companies from 21 different countries began trials in Q1 in Russia, with the most coming from local sponsors, while US sponsors accounted for 24 new studies. The top five sponsors were Janssen (eight new studies in the quarter), Boehringer Ingelheim, Merck, Genentech and GlaxoSmithKline.  

As far as therapeutic areas, 74% of new studies in Q1 2015 were initiated in eight areas, with the largest number coming in oncology (18). Twelve new studies were initiated in pulmonology, while nine were set up to study musculoskeletal disease treatments, seven studies focus on circulatory system diseases, and another seven were started in neurology.

Stefanov told us that companies are increasingly coming to Russia to conduct trials because of the “Russian Troika​,” which involves high patient recruitment, high quality data confirmed by almost 100 US FDA inspections since 1995, and the reduced cost of running a trial compared to the US or EU, which is “exactly what global pharma needs in today’s R&D crisis​.”

Early phase research also seems to be seeing the same resurgence in Russia that it’s seeing elsewhere. Phase I and Phase II clinical trials both nearly doubled in Q1 when compared to the same quarter last year, while the number of Phase III trials decreased from 81 to 68 studies.

India Comparison

And although Russia is still considered an emerging market when it comes to clinical trials, the country is faring far better than its BRIC (Brazil, Russia, India, China) counterpart India, which has approved only 15 clinical trials​ between January and March of this year, including one from CRO INC Research. By comparison, 76 trials were approved between January and May of last year​.

The fall in clinical trial approvals for India could be a sign that regulations governing trials have made it more difficult to start research on the subcontinent.

According to Two Four Insight Group​, only two-thirds of the recent trial applications were approved, while 16 SECs (subject expert committees) and one MDAC (Medical Device Advisory Committee) met at least once to discuss the applications.

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