| The former USSR could be a valuable region for the pharmaceutical industry. Vladimir V Novakovskiy at Congenix LLC assesses Russia’s burgeoning capacity for clinical trials
The drug development services industry constitutes a significant, ever-expanding portion of all pharmaceutical and biotechnology drug development activity. The sponsor companies in the life science industry are continually striving to seek more efficient and cost saving methods to bring compounds to market. Offshoring to countries outside of the US and Western Europe is one strategy to help reduce costs. This is a vital consideration, especially as regards the cost range of bringing a new product to market is $800 million to $1 billion, and only one in five commercial products will generate a profit. It is evident that offshoring trials is increasingly becoming the norm in clinical research. The number of FDA-sanctioned offshore trials increased from 1,000 in 1991 to 7,000 in 2000, while the percentage of NDA submissions to the FDA that includes data generated from offshore trials has increased dramatically over the last five years.
In these circumstances, the market for clinical research services in Russia and Russian-speaking countries is particularly attractive to sponsor companies. The benefits of conducting clinical trials in Russia include an effective clinical trials authorisation system, and a medical system comprising a huge population of potential investigators and trial subjects.
THE DEVELOPMENT OF RUSSIAN REGULATION
Large-scale clinical trials have been conducted in Russia since 1989. The major driver for the increased interest from Western pharmaceutical companies to include Russian sites in multinational projects is the enormous enrolment potential, which offers a solution to the intense competition for patients among clinical trials in North America and Western Europe. There are a large number of highly specialised hospitals, and thus from a design perspective they are highly suitable for clinical research.
However, when interest in Russia first began in 1989 the clinical trials were not governed by any regulations. Whilst the Constitution of the USSR protected patients’ rights to some extent, further ethics committees were yet to be established for the proper regulation of trials. It was a full 10 years before the official text of ICH GCP was published in Russian. The Russian language version of GCP – National Standard OST 42-511-99, a close translation of ICH GCP – became a part of national regulations on clinical research. The legal basis underpinning clinical trials in Russia is the federal ‘law on drugs’ of 1998, with numerous additional modifications. For example, the latest important modification countermands the statement that the investigators cannot receive grants from the sponsors for their participation in clinical trials. |
