A temporary ban on the export of biological samples from Russia in May and June was blamed for a 13% fall in the number of clinical trial permits issued by the country’s Federal Agency for Health Care and Social Development (Roszdravnadzor) during the second quarter of 2007.
A total of 114 permits to conduct clinical trials in Russia were issued in the second quarter, compared with 131 in the same period of 2006. This contrasted sharply with the first quarter of the year, when the number of trials approved by Roszdravnadzor jumped by 38% to 134, according to data from Moscow-based contract research organisation (CRO) Synergy Research Group.
In Synergy Research’s latest report, the decline in approvals for international multicentre studies was particularly marked, with a drop of 25% to 64 for the second quarter. The number of permits for trials conducted exclusively in Russia stayed relatively stable at 29 versus 28, as did the figure for bioequivalence studies (21 in Q2 2007, 19 in Q2 2006).
This suggested the action taken by the Russian Federal Customs Service on 29 May was the main culprit. The ban on exporting biological materials, which lasted for nearly two weeks and included clinical trial samples, led to a steep decline in the number of applications for international multicentre clinical trials (IMCTs) in Russia, Synergy Research noted. “If there had been no ban, the number of IMCTs could have grown by 50% and June would not have been ‘lost’,” it added.
The reasons for the ban remain somewhat murky. The customs service said it was to stop illegal trade in human organs and tissues, although Synergy Research described the move as “unexpected and unexplainable”, commenting: “Events of this type do not stimulate the flow of international clinical trials to Russia”.
The CRO is confident, though, that the damage is short-lived. According to available data, “we can assume that the demarche will not produce any effect on the favourable development of the clinical trials market in Russia in the long run, and May 29, 2007 will not become the ‘Black Tuesday’ for the Russian clinical trials market,” it said.
The decline in multicentre trials during the second quarter meant there was a continued growth trend in the number of studies initiated by Russian sponsors. These increased by 7% to 40 in the quarter, making up 35% of all trials granted permits by Roszdravnadzor. The number of approved trials with international sponsors fell by 21% to 74. Among the most active of these were sponsors from the US (17% of approved trials), Switzerland (11%), Germany (7%) and the UK (6%).
The leading international sponsor was Roche, with 10 Russian trials involving 1,042 patients at 89 sites started during the second quarter. Novartis had six trials approved while GlaxoSmithKline and Merck & Co scored four apiece. The leading Russian sponsor was Severnaya Zvezda (four trials started with 72 patients at four sites), followed by Biocad and RozPharm (three trials each).
Phase II and III studies suffered most from the general decline in Russian approvals during the second quarter. The number of Phase II trials dropped by 26% to 35 while Phase III trials were 27% down at 40. The number of Phase I studies edged up slightly to seven from six in Q2 2006 and Phase IV trials showed a significant increase of 70% to 19 in the review period.