The number of investigative sites that have been re-accredited by the Russian Ministry of Health (MoH)—a requirement inherent in the country’s new regulations—is now up to almost 600, according to the Association of Clinical Trials Organizations (ACTO), a trade group for those working in research in Russia.
An August report from Synergy Research Group that scrutinized second-quarter numbers had showed just over 150 sites re-accredited, alarming some who conduct clinical trials in Russia. But the MoH, which has been re-accrediting sites in batches and pushing sites to submit re-accreditation paperwork by Sept. 1, has largely caught up since the second quarter. As of Sept. 1, 596 sites were re-accredited and ready to take on clinical research studies.
“This certainly provides the critical mass needed for anyone who wants to do studies in Russia,” said David Passov, CEO of the Russia-centric but San Francisco-based CRO ClinStar. He predicts a few hundred more Russian sites will seek re-accreditation even though the deadline has passed. He estimates there are a total of about 1,100 investigative sites throughout Russia, but not all are active.
The timelines in Russia are still not great, though. When the country reworked its regulatory process last year, transferring clinical research regulations from the Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation (Roszdravnadzor) to the MoH, the MoH set a goal of reducing approval timelines to 65 calendar days, said Passov. But currently the average approval timeline in Russia is about double, according to ACTO.
The Synergy research, published as an orange paper in August, indicated that only 114 clinical studies were approved by the MoH in the second quarter, down 36% from the same period in 2010. Local CROs had only 14 trials approved in the period, down from 64 in the second quarter of last year, while multinational, multi-center trials saw their numbers rise. In this year’s second quarter 91 were approved, compared with 71 during the same period last year. The number of bioequivalence studies was lower, at nine compared with 33 in the second quarter of 2010. And the number of patients expected to be enrolled in phase I-IV trials dropped 27% from 15,287 in the second quarter of 2010 to 11,203 during the same period this year.
Passov said he thinks the dust will settle soon. “The transfer of approvals from one department to another took some time, the ethics committee was dissolved and a new entity created, and there were some pains in putting the new regulations in place,” he said. “But now everything is settling in fairly well.”
In the meantime, though, many of those considering conducting trials in Russia are apprehensive. “At every conference I go to, I get questions about how the new regulations are affecting people’s ability to conduct studies in Russia,” said Passov. “But if you’re local and in touch with local requirements and local realities, then it’s very manageable.”
According to the report from Synergy, a Russia-based CRO, more than a half of all new studies in Russia in the second quarter of 2011 were focused in seven therapeutic areas: oncology, cardiology, infectious diseases, rheumatology, endocrinology, pulmonology and psychiatry.
Clinstar manages phase I-IV clinical trials in Russia, Ukraine, Belarus and the Baltic States. It has 250 employees, 240 of whom are spread among Moscow, St. Petersburg, Kiev and Minsk.