Infrastructure factors have been evolving in Russia during the last decade. Eventually, the potential the country holds in terms of qualified investigators and well-structured clinical site management allowed Russia to participate actively in rapidly advancing and highly competitive field of medication development along with other multinational teams of scientists already involved in clinical research.
Presented in this article is the outline of the current statutory norms regulating the field of clinical research in Russia.
Requirements and Functions of Regulatory Bodies
Russian state regulations provide forboth:
- patients’ security and defense of their rights and health;
- systematic collection of authentic clinical data.
Rules of conducting clinical studies are brought into compliance with international regulations such as ICH GCP standards. The main document regularizing conduct of clinical studies in Russia is the federal law on medical products.
Roszdravnadzor (the Federal Service on Surveillance in Healthcare and Social Development of Russian Federation) maintains the following functions:
- control over of pre-clinical and clinical studies of drugs, assessment of compliance with the standards of quality laboratory and clinical practice (GLP), inspection of clinical sites and other institutions involved in clinical trials;
- issue of permits for conducting clinical research;
- issue of permits for importation of non-registered drugs intended for the use in clinical trials;
- issue and updating of the list of medical organizations allowed to implement clinical trials.
Most popular clinical trial areas in Russia are oncology, cardiology, virulent diseases, endocrinology and psychiatry.
Generally, conducted in Russia are all phases of clinical trials, but Phase III makes the greatest number among them. Thus, 61% of international clinical studies conducted in 2005 were Phase III trials.
Involved in clinical research are Russian pharma companies as well as international sponsors and CROs, with the latter recently growing steadily in number.
Selection of Clinical Sites
The key factor determining the success of clinical study is the correct selection of qualified healthcare facilities capable of:
- fast patient recruitment
- strict protocol adherence
- reliable data delivery
To gain a permission to conduct a clinical trial for clinical research form the Ministry of Public Health and Social Development, the Principal investigator of the organization should submit information about their experience in conducting that kind of research, as well as demonstrate clear understanding of international principles of clinical practice quality.
Another crucial criterion in selection of investigators and CROs is the knowledge of English language. As a rule, the staff has a good command of English (reading and writing), and there is no need in having registration cards translated into Russian. And even though protocols are usually translated for submission to regulatory authorities, a lot of investigators prefer using the original English language documents in their work.
In some sites the staff may have minor problems with spoken English; nevertheless most sites can provide at least one fluent speaker of English out of its staff.
The growth of information technologies facilitates conducting investigators with remote data capture (RDC), so the sites located in cities are equipped with reliable access to the internet.
The list of healthcare facilities allowed by Roszdravnadzor to conduct clinical trials can be found on the organization’s website – www.roszdravnadzor.ru – and is regularly updated.
Locations of Clinical Sites
The majority of clinical sites in Russia are treatment and preventive care facilities. According to the research conducted by one of the largest international CROs, Covance, among 221 sites, 87 of them (39.4%) are located in Moscow and 47 (21.3%) in Saint-Petersburg. The clinical study market in these two cities is close to saturation;hence the interest of pharma industry to new regions of the country is quite reasonable.
The growth of clinical trial popularity in Russia and development of crucial infrastructure in remote areas of the country gave rise to a lot of new sites in other cities – from central parts till Far East of Russia. In big cities with high population density and availability of specialized medical facilities, recruiting patients for clinical research is fast and easy.
Required Permissions for Conducting a Clinical Study
When issuing a permission for conducting a clinical research, the Federal body makes its decision basing on:
- the drug’s characteristics
- scientific argumentation for conducting the research
- patients’ interests
Additionally, another permission is required from Ethics Committee affiliated with the Federal Agency for Quality control of Medical Products.
Import and Export of Clinical Study Materials
permission issued by the Ministry of Public Health and Social Development are required for both import and export of materials for clinical research.
Permission for import of an agent is issued only per consignment (with a clearly mentioned quantity) of a non-registered drug. A new permit should be obtained for every new consignment of the drug.
To obtain the document, a written application must be submitted along with calculations supporting the necessity of the drug’s or agent’s claimed amount.
Export of research materials requires a permit from the same body. This document is issued based on the application containing information about both used and unused amounts of the drug. To export patients’ bioassay tests (like blood, urine, etc.), you will need a permit issued by Roszdravnadzor.
Russia has the required infrastructure and conditions for conducting quality and reliable clinical trials. Recruitment opportunities are excellent, with Russian patients demonstrating a high level of willingness to continue with the trial from the beginning to its end. Actually, only 14% of Russian patients leave the trial before its end, while in other countries this percentage is about 24%.