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The opening of Kendle’s new office in Moscow further strengthens our global clinical development capabilities in Phase II-IV and builds on our strong base of operations in Central and Eastern Europe (CEE). Crucially, it also unlocks a huge population base of more than 142 million for a pharmaceutical company seeking a clinical trial location.
Advantages to conducting clinical trials in Russia
Importantly, costs associated with clinical trials in Russia are significantly lower than countries in Western Europe.(3) The main specialized clinics and institutes are located in urban areas such as Moscow, St. Petersburg, Samara, Rostov and Novosibirsk(1), which means that most patients are seen at the large teaching hospitals – the only centers where clinical trials are authorized in these areas. Therefore, even recruiting patients with relatively rare conditions is often easier than in countries with a greater emphasis on primary healthcare. Russia also has a high ratio of hospital beds to population – 12.1 per 1,000 people in 19983, enhancing its attractiveness.
The medical conditions most frequently causing death in Russia are similar to those in other European countries: heart disease, cancer, stroke, respiratory diseases and diabetes. At the same time, disease incidence in Russia is higher than in the West. Despite these characteristics, preventative healthcare is a low priority in Russia, so the proportion of previously untreated patients is high. Also, once patients have been recruited, compliance rates are good and dropout rates are low.(3)
High level of health knowledge
Russia's educational system has produced nearly 100% literacy(2), which makes trial recruitment more straightforward. Also, patients in Russia tend to be enthusiastic about participating in clinical trials that allow them access to higher standards of medical care than they could not otherwise afford. This is borne out by an estimated rise of more than 60 percent in 2004 in the number of Russians participating in clinical trials.
Because a great emphasis is placed on science and technology in education, Russian medical, mathematical and scientific research is generally of a high order. CRAs and project managers involved in clinical trials are all medically qualified,(3) and Russian investigators are well-trained and experienced in Phases II-IV. The majority receive their GCP training through pharmaceutical companies and CROs. More than 60 percent of clinical investigators hold a PhD, and 40 percent teach at major universities. Highly motivated investigators at hundreds of Russian sites recruit thousands of subjects and provide data of the highest possible quality, something repeatedly confirmed by FDA audits.
Favorable regulatory environment
Russia’s government has taken proactive steps to open up its health systems to foreign clinical research. Clinical trials in Russia are GCP-compliant and performed in strict accordance with international scientific and ethical standards, which serve as a guarantee of safety, protection of rights and health of the subjects, as well as validity of trials’ results. Obtaining authorization from the Russian Ministry of Health (MoH) is fairly straightforward, and in 2004 the MoH approved more than 500 new projects, including more than 250 international studies and more than 100 bioequivalence studies. The Russian government has also created a central review process and most major hospitals have a review committee.
- Cardiovascular
- HIV/AIDS
- Oncology
- Respiratory
- Central nervous system
- Endocrinology
- Dermatology
- Blood disorders
- Inflammatory disease
- Rheumatology
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