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TRENDS & PERSPECTIVES

Healthy Pipeline of Clinical Trials in Russia

R

ussia's global clinical research market has grown substantially in the past five years. But, relative to Russia's population of nearly 143 million, there is enormous potential for future growth, given that only 42,000 patients were enrolled in global clinical trials in the country last year. FDA and EMEA have begun approving drugs with clinical trial data from Russian sites, a mark of quality. That, along with rapid patient enrollment, has helped Russia emerge as an attractive clinical research market. While clinical research has been conducted in the country since the 1990s, big pharma has only recently begun to regard Russia as a potential future market for their drugs. Russia has all the typical hallmarks of an important emerging clinical research market. The country boasts a population of 143 million, made up of mostly treatment-naïve patients; a centralized healthcare system comprising very large hospitals, each specializing in one therapeutic area; a regulatory system that has become increasingly transparent and streamlined; a pool of physicians eager to conduct clinical research; and potential for sustained future growth. The growth of Russia's clinical research market in the past five or so years has been impressive. Nearly double the number of clinical trials were approved in 2006 as were in 2000, the number of patients participating in global clinical trials conducted in Russia more than tripled between 2002 and 2006, and Form FDA 1572s were filed by

more than triple the investigators in Russia between 2001 and 2006. The most distinguishing factor propelling Russia's growth, attracting pharmaceutical and biotech companies and contract research organizations (CROs) from around the world is the solid reputation for clinical research that the country has built up over the past decade. Drugs developed with data coming from studies conducted in Russia have begun to be approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA)--the most important quality marker an emerging country could attain. "There are a lot of companies that have already done studies in Russia, have taken the risk, come here and done the study. Then, a lot of people came to know the fact that clinical trials can be done in Russia and the data are of high quality and they are accepted, so this is selfadvertisement," said Sumit Seth, M.D., country manager, Russia, Trial Form Support (TFS), a CRO founded in 1996 with offices in Russia, Scandinavia, Western Europe, the Baltic States, India and Japan. TFS Russia was established in 2005 with Seth as its only employee. The office now employs eight and has five active trials from U.S., Japanese and European companies. Seth expects to double the number of employees this year and have at least seven more new studies. Jean-Pierre Tassignon, M.D., Ph.D., president and CEO, Pharma Support International (PSI), added, "We've gone full cycle from the beginning where people were setting up their trials there, and

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