International, multicentre trial approvals soar in Russia in 2011
According to a new report by Moscow-based contract research organisation (CRO) Synergy Research Group, a total of 571 new clinical trials were given the green light in the 12-months to December 31, which is a 16 per cent increase on the total in 2010.
Of these clinical studies 369 – roughly two thirds of the total conducted in 2011- were international, multicentre trials, which is an increase of 49 per cent on the number cleared the previous year.
In contrast the number of local trials – those conducted in Russia only – approved by the MoH in 2011 fell, down 27 per cent to 117. The number of bioequivalence trials – required for the launch of a generic drug product in Russia – increased by one on 2010 to 85 trials.
Whether this indicates the MoH is preferentially reviewing international studies is unclear - and as yet neither Synergy nor the MoH have responded to Outsourcing-pharma.com's request for comment.
There was also a marked increase in the proportion of studies - of all types - conducted by international firms in 2011, up from 282 or just under 40 per cent of the total, to 402, or just over 70 per cent.
ACTO
The Synergy report findings follow just weeks after CRO industry group, the Moscow-based Association of Clinical Trial Organisations (ACTO), commended the MoH for the number of multinational, multicentre clinical trials it approved in 2011.
It said that: “In analysing the results of 2011 we can conclude that crisis of 2010, created by the reorganisation of the regulatory approval system and transfer of approval authority from Roszdravnadzor to the Health Ministry [under the On the Circulation of Medicines legislation], has been overcome.
“We believe that the good results for IMCTs are a result of the hard work of the clinical trials department at the Health Ministry."
ACTO also observed the relative decline in the number of Russia-only studies in 2011, however, it suggested the complexity of such studies was behind the decline.
“It is possible that this decline is the result of the new law’s intent to build local trials into the registration system, as now it is only possible to commence such trials if you have already launched the registration process.”
