After gathering and analyzing data, the Association of Clinical Trials Organizations (ACTO) has concluded that the 2010 crisis brought on by Russia’s new regulations and the transfer of approval authority from Roszdravnadzor to the Health Ministry has been resolved.

Reflecting this conclusion is the 2011 annual data, as well as the resolution of many issues presented in the new legislature, such as the ban on importing registered medicinal products, trial participant insurance issues and medical institute re-accreditation.

In its most recent newsletter, ACTO said Russia approved 567 clinical trials in 2011, a decrease of 1.7% from 2009 and an increase of 17.6% from 2010, when new regulations resulted in an unusually low number of requests.

Of the 567 approvals, 370 were international multicenter clinical trials—a record high since recorded statistics began in 2004 and a 6.3% increase from 2009. Other types approved in 2011 included 35 local trials with foreign sponsors (+9.4%), 19 bioequivalence studies with foreign sponsors (+137.5%), 80 local trials with local sponsors (-28.6%) and 63 bioequivalent studies with local sponsors (-18.2%).

Despite the unusually low numbers in 2010, there was still a notable decrease in all local sponsor trial and study approvals from 2010 (200) to 2011 (143), the lowest in the last seven years. This decrease could be in correlation with the sudden increase in international multicenter trials, which accounted for 65.3% of the 2011 total. Since Russian CROs were joining these trials instead of conducting local trials, a subsequent decrease in local trial numbers would occur.

Furthermore, the local sponsored bioequivalence studies showed only a small decrease, while the local sponsored local trials for safety and efficacy were more significant.  ACTO suggested, “It is possible that this decline is the result of the new law’s requirement that local trials should be built into the registration system, as now it is only possible to commence such trials only if you have already launched the registration process.”

Breaking down 2011, the fourth quarter was by far the most productive with 234 approvals—nearly double the activity in any other quarter: 82 in the first quarter, 119 in the second and 132 in the third. More specifically, of the 19 approved bioequivalence studies with foreign sponsors in 2011, 16 were approved in the fourth quarter. This sudden increase could be due to the eight-month ban on imported registered medical products, which was lifted in June 2011. With the ban’s lift, CROs wishing to conduct bioequivalence studies could finally gain access to the drugs they wished to test, and therefore were able to request approval for trials. Since the time between requesting and gaining approval for trials is so long, trials registered in the summer would not be approved until the fourth quarter.

Broadening its analysis, ACTO also compared the 2011 data with the Russian clinical trials market overall. While most 2011 data stayed relatively the same as the market structure, there were a few dramatic contrasts. Most notably, the bioequivalence studies—which doubled in their total share of approvals from 1.6% to 3.4%— and the local sponsored local trials—which decreased from a typical 20.6% to 14.1%. More specifically, foreign sponsored trials’ requests for certain phases were unusual. This was due to the “On Circulation Medicine” law, which prohibits phase I trials of foreign medicinal products in healthy volunteers. ACTO explained, “In the first half of 2011 we saw a decline in the share of phase I trials to 1.7% (down from 5.7% in 2010) and it should be noted that previously this indicator had been growing steadily since 2004.”

Instead, other phases took precedence, with phase III trials increasing from 54.8% to 60.6% of all trials. Phase IV trials results were also unusual, specifically on a quarterly basis. “While in the first three quarters the overwhelming majority of post-registration trials were [international] and the number of local post-registration trials was insignificant, in the fourth quarter the distribution has changed, and out of 14 approved phase IV trials only one was [international],” reported ACTO. The organization was unwilling to draw any conclusions, but noted its plans to monitor the dynamic in the future.

Overall, ACTO regarded the 2011 data as “acceptable and on a number of indicators even positive.” However, the organization said Russian clinical trials are still suffering from regulatory and administrative issues. The timeframe for issuing approvals has always been difficult, and although unsatisfactory under Roszdravnadzor, the issue has become exacerbated under the Health Ministry. After six months of monitoring, ACTO found the Health Ministry has increased waiting time by 30%, and in some cases the waiting time is actually two to four times longer than designated in the law. ACTO suggested adopting new regulations that clearly specify timelines or, instead, removing the requirement to re-file documents to conduct trials (which forces international trials to apply twice for approval).

ACTO noted two other issues it said could be resolved easily by changes in legislation: “the artificial limitations on doctors’ access to participation in clinical trials by instituting a mandatory level of experience in clinical trials (five years compared to two years in the early version) [and] the mandatory accreditation procedure for medical institutions (previously achieved by notifications).”

ACTO’s next newsletter will focus on its year-long monitoring of the approval timeline.

By Kris Vetter