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Russian MoH OKs nearly 600 sites for trials

By Gareth MacDonald+

20-Sep-2011

The Russian Ministry of Health (MoH) has cleared nearly 600 trial sites for clinical research, easing concerns that the reaccreditation process was taking too long.

Data on the Association of Clinical Trial Organisation's (ACTO) website shows that, to date, the MoH has approved 596 sites to conduct studies, which is a requirement under Government Decree No 683 that came into effect on September 1.

This is a significant increase on the number approved at the end of June, which at just 115 according to analysis conducted by Moscow CRO Synergy Research Group, had the potential to become a problem for the Russian clinical research sector.

At the time Synergy CEO Igor Stefanov told Outsourcing-pharma.com the MoH had devoted only ‘limited resources’ to site accreditation after taking over the responsibility for such work from the Roszdravnadzor in 2010.

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.”

Minimum threshold

These concerns were echoed by ACTO in its newsletter a month later, when it revealed that although the number of approved sites had increased to 152 by the end of July, there was still a shortfall.

According to expert evaluation, the minimum number of medical institutions required to meet the needs of the market is 500 to 600. Thus, a month before the new accreditation regulation came into force, not more than 30 per cent of the number of clinics sufficient for normal functioning of the market could actually be accredited.

This and worries that “the Ministry of Healthcare and Social Development will shift the blame on the applicants” prompted ACTO to create a free-to-access database of approved sites using information from member organisations and clinics across the country.

Batch release?

Whether such concerns were ever justified or the database was necessary is difficult to say given that – according to ACTO’s own data - the 500 to 600 site threshold was met ahead of the deadline.

Comments emailed to Outsourcing-pharma.com by ClinStar in response to an article on site approval earlier this year may indicate the situation had started to resolve itself at the end of the summer.

While it is true that the number of investigative sites receiving re-accreditation in Russia was indeed around 150 in mid-July when Synergy Research Group was preparing their Q2 2011 Orange Paper, fortunately the situation has improved significantly.

Appreciating the importance of the re-accreditation process, the MoH has reaccredited another 200 plus sites, bringing the overall total up to 411,” ClinStar said, going on to explain that the organisation makes accreditations known to the public in bulk.

The US-headquartered CRO, which has extensive operations in Russia, also predicted, accurately it turns out, that the MoHwould reaccredit "600 sites by September 1, thereby providing enough critical mass to continue ongoing studies without interruption, allow approvals of new studies and enable Russia to retain its attractiveness as a desirable geographical region for clinical research.”

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