Overcoming Clinical Challenges in Russia

Slated to rise from 11th to eighth place in the global pharmaceutical rankings, Russia is steadily proving to be a lucrative market for investors. With increased healthcare expenditure and governmental support of innovation through the implementation of Strategy 2020, policymaking and industry reform are shaping Russia’s drug development landscape. Efforts to localize pharmaceutical manufacturing and increase domestic R&D standing have been successful. Most of large pharma has set up camp in the country and remains present despite a drop in clinical trials in 2013. With an “on-the-ground” presence, sponsors are able to take advantage of the benefits to running clinical trials in Russia.

Although modernizing, with plans for a largescale reform being implemented, the national healthcare system of Russia remains inadequate. Compulsory Health Insurance is intermixed with private insurance and most feel the system is complex and inefficient. Citizens complain of a lack of trust and funding, leaving them with high out-of-pocket expenses. This disengagement from the healthcare system results in a large, mostly treatment-naive patient pool concentrated in major cities, namely Moscow and St. Petersburg, and other benefits such as fast enrollment and patient retention.As Putin’s healthcare reform takes shape, however, the quality of medical institutions and clinical laboratories is increasing.

In 2013, the FDA conducted two clinical trial inspections in Russia; both passed with only voluntary actions suggested. This speaks to the high quality of clinical data produced in the country as well as the training and performance of its investigators. Despite their expertise, Russian investigators experience lower grant funding and require lower fees than their Western counterparts. With an average cost-savings of 60 to 70 percent per clinical trial patent, it is easy to see why big pharma is growing roots in Russia. The Ministry of Health of the Russian Federation (MoH) accredits medical institutions in the country (ensuring ICH-GCP compliance), approves preclinical and clinical trials, and grants import/ export licenses for investigational drugs and biological samples. A clinical trial application must go through the MoH where it is then submitted to the Ethics Board and to the Federal State Institution “Scientific Center of Medicines Expertise of RZN ” (FSI SCMER) for scientific review. Once approved, the application receives the go ahead from the local ethics committee of each participating medical institution. As the trial is underway, the Federal Surveillance in Healthcare (Roszdravnadzor – RZN) performs assessments, as well as maintains the clinical trials database and ensures pharmacovigilence and risk management.

Number of Clinical Trials Initiated in Russia from 2009-2013 by Sponsor (Source: Cortellis Clinical Trials Intelligence)

While change, especially in emergent countries like Russia and India, is both coveted and necessary, the upheaval of the healthcare system and the
tumultuous regulatory landscape are seen as primary barriers to clinical development in Russia. Sponsors and contract research organizations (CROs) argue that it is difficult to keep up with consistently changing regulations, causing delays in trial timelines and decreasing the expected cost-effectiveness. Current timelines in Russia average three to four months. Unethical conduct is another caveat in the country as revealed in several surveys and remarks by pharma. Biogen Idec provided an example at the Global Clinical Trials Conference: in 2013, the company shut down all sites for a phase II trial (one quarter of the study’s patients) in Russia, because investigators did not want their trial income reported to the state employers.

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