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Russia corners the market of clinical trials

Russia corners the market of clinical trials

Publish date: 2012-11-29

Lately, increased activity in clinical trials could be observed in the Russian market. Only in the second quarter of 2012 275 trials were approved, which is a 44% jump from the same period in 2011. According to Vladimir Putin words, Russia aims for being a super power in the sector of biomedicine and biotechnology by 2020, so could this be a signal that the Russian offensive has already started?

Tags: biotechnology , pharma , russia

Recently, the government of Russia implemented the law concerning cheaper and faster procedures of conducting clinical trials comparing to USA or Western Europe. Due to lower costs and legal regulations combined with increased public and private investment in drug market, there is a growing interest within companies to develop their work in Russia.   

For a better understanding consider that the development of a new drug in United States takes at least 10 years, while in Russia just 5. One of the explanations for shorter timeframe in Russia is the ease of recruiting the patients for clinical trials. Unlike in other countries, patients also have a tendency to stay on trials once enrolled, which significantly facilitates carrying the next phases of clinical experiments.

The important factor that shortens the timeframe of trials in Russia is also a very small number of patients involved in the Phase III stage providing that your drug exhibited a strong effectiveness in clinical practice. It means that if you already know the optimal conditions for your drug and you can prove its effectiveness and safety the Phase III trials are not as expensive and time consuming as in the USA.

How much cheaper? Depending on the source of information, the costs are estimated on less $100 million comparing to 1 billion dollars or more in the United States. The difference arises from simplified regulation of patients’ recruitment, which can save up even $15 million for only Phase III trial. Though, it has to be highlighted that the quality of researches conducted in Russia are regarded as high enough to receive approvals from FDA and EMA – agencies approving drug use in Russia. It seems that in the following years, the only treat to well-prospecting clinic trials market in Russia may be the growing competition from countries like India, China or Brazil.

Source: biotechnologia.pl

Ewa Sankowska, translated by: Jacek Plewka

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