He is like thousands of others at hospitals across Russia who are participating in clinical trials of all types, run by almost every major Western pharmaceutical company.
The nation's centralized hospital system makes recruitment for trials quick and easy, which in turn makes them relatively cheap for Western sponsors.
Patients can be recruited 10 times faster in Russia than in the U.S., doctors say, shaving precious time and millions of dollars off the drug-development cycle.
From Azerbaijan to Nigeria, pharmaceutical companies are increasingly shifting clinical trials to emerging markets - as much as 40% of all drug trials this year [2005], according to several pharmaceutical executives, up from about 10% in 1999.
Merck's Vioxx & Zocor were tested in Russia and other developing countries, as were many of Pfizer's billion-dollar drugs, before gaining approval in the U.S.
Working in countries such as Russia, says Pfizer senior VP Adrian Otte, can cut 3 to 6 months off a trial, meaning a drug can get to market that much faster.
And the trials are cheaper. GlaxoSmithKline CEO Jean-Paul Garnier says that 1/3 of his company's trials now take place in low-cost countries, and he aims to hit 50% within 2 years. Why? Running a trial in the U.S. costs about $30,000 per patient. He can do it in Romania for $3,000.
The FDA encourages testing on ethnically diverse populations, hoping for more insight into the ways drugs can affect different people. And drug companies are hoping to penetrate new markets. Russia's drug market is estimated at $5 billion this year, India's at $5.4 billion.
…foreign patients - they are eager to sign up because they lack a viable alternative and tend to have blind faith in medicine. "Patients believe in doctors more here," says Dr. Viktor Kostenko, who has been the chief investigator for 11 drug trials in St. Petersburg.
Russia's centralized health system means that hundreds of patients with similar symptoms are congregated in the same place, like Kostenko's ward. Many of them are what the industry calls "treatment naive," meaning they have not built up resistance to new drugs from years of antibiotic treatment, and their diseases are often advanced. They offer a perfect baseline for scientific study.
…it is clear why many of Russia's best doctors are migrating to the trials industry. Kostenko recently enrolled 200 heart-attack patients for a drug trial in his ward. Between the database and the financial incentive for doctors to recruit efficiently, things happen fast in Russia.
When a trial runs slowly in the West, it is often brought to Russia to make up for lost time. In 1999 the New England Research Institutes, a CRO specializing in public health research, began a multicenter intl. trial to test the effectiveness of magnesium sulfate on heart-attack patients. After 18 months of recruitment in Canada and the U.S., fewer than 300 patients had been found. The trial was on the verge of collapse when the study's sponsors contacted a California CRO, Evidence Clinical & Pharmaceutical Research. In little more than a year, Evidence recruited an additional 5,600 patients, mostly in Russia but also in Bulgaria and the former Soviet republic of Georgia. PSI Pharma, the largest CRO operating in Russia, recruited 2,400 patients in just 2 weeks for a Ph.3 trial of a hypertension drug. In that time Belgian investigators enrolled only 20 patients.
Hired as middlemen by the drug companies, the CRO’s in turn find and pay the doctors, mine for patients, and provide local expertise and regulatory experience. As trials have increasingly spread around the globe, the CRO industry, estimated at $11 billion this year by CenterWatch, a market-research company, has flourished.
These internationally accepted guidelines, known as Good Clinical Practice, require the establishment of local review boards; ask government health ministries to approve all trials before they begin; warn against excessive payment to doctors; and outline how to obtain informed consent and avoid taking advantage of vulnerable patients.
Trials will continue to shift to poorer countries in search of more patients, lower costs, and faster recruitment. Right now Russia is the frontier, but as it gains experience and improves its research standards, costs will inevitably go up. Drug companies are already well established in Poland and the Czech Republic and are looking farther east for new testing grounds. "Eastern Europe has maybe 3 years," says Ken Getz, founder of the Center for Information and Study on Clinical Research Participation, which monitors drug research. "India has 5, and China hasn't even started counting."
= = = = = = = = “Healthy Pipeline of Clinical Trials in Russia” The CenterWatch Monthly – April 2007 “10 years ago, the pharmaceutical companies did not look at Russia as a possible market for their new compounds. So it was a market for clinical research but not a market for future sales. Currently, I think that the pharmaceutical companies understand that Russia is a future market. That’s the biggest change and definitely an advantage,” said Sergei Varshavsky, M.D., Ph.D., chairman and chief executive officer, Evidence Clinical and Pharmaceutical Research Institute, a CRO http://www.evidence-cpr.com that has an academic focus and has been conducting clinical trials in Russia since 1989. Evidence has offices in St. Petersburg, Moscow, Siberia, and the Republic of Georgia, as well as Ukraine, with headquarters in the U.S. The CRO has recruited more than 30,000 patients. Evidence has tripled in size in the past 5 years. TFS’s Seth agreed, “One of the new reasons why people come to Russia to conduct a clinical trial is for the Russian market. If a sponsor is doing a phase III study, the company may be interested in including Russia as a future market for the drug. Lately this has been one of the reasons why more and more companies come to Russia.” http://www.cro-rct.com/media/press/cwap.pdf
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