The market for clinical trials in Russia continued on a strong recovery track during the fourth quarter of 2007, with the number of trial approvals by the Federal Agency for Health Care and Social Development (Roszdravnadzor/RZN) up by 23.4% over the final quarter of 2006 to 174.

As the latest report from Moscow-based contract research organisation (CRO) Synergy Research Group points out, the main driver for this growth was international multicentre trials. The RZN issued permits for a record 131 of these during Q4, 54.1% more than in the same quarter of 2006.

That took the share of international multicentre studies in the overall approval spectrum up from 60% to 75%, while local trials and bioequivalence studies dropped from 20% to 18% of the total and from 20% to 7% respectively. The RZN granted 31 permits for local trials in the fourth quarter of last year, a 10.7% increase on Q4 2006, and 12 permits for bioequivalence studies (-57.1%).

The breakdown of trials by sponsor in the latest quarter showed a similar trend, with foreign sponsors accounting for 82% of all studies initiated (62% in Q4 2006) and Russian sponsors for 18% (38%). In particular, the figures show how much confidence has returned to the market following the temporary ban on the export of biological samples imposed by the Russian Federal Customs Service in late May 2007.

That move was blamed for a 13% fall in the number of clinical trial permits issued by Roszdravnadzor during the second quarter of 2007, including a 25% decline in approvals for international multicentre trials. It also prompted the formation last November of the Association of Clinical Trials Organizations (ACTO), bringing together the interests of companies in the field and the wider clinical research community.

ACTO’s main objectives include:

- Further developing Russia as a leading market for clinical research through capacity-building and activities to shape the professional environment
- Generating awareness of clinical research as a speciality and establishing a good reputation among the general public and government agencies
- Creating a favorable business environment for companies conducting clinical trials in Russia
- Maintaining constructive dialogue with regulatory authorities and the general public, with the aim of developing a stable local legislative basis for clinical trials conducted in accordance with global standards
- Promoting an ethical business model for clinical research in Russia
- Ensuring a proper and effective balance between the interests of all stakeholders in clinical trials, including patients, the medical community, the general public and government agencies.

The association was founded by seven contract research organisations, namely Almedis, Evidence, MB Quest, Parexel, PharmaNet, Quintiles and Synergy Research Group.