The author, Barbara M. Bolten, cites different opinions of the industry experts. Generally, offshoring from developed countries to other regions can significantly lower the cost of a study. However some of the interviewees argue that if there are data issues, rather than decreasing, the costs can even be higher compared to the US or Western Europe. At the same time, as one of the speakers puts it, whereas clinical trials in China and India have face issues with data integrity, “Russia and Eastern Europe are lower cost regions that tend to produce reliable data.”
“We see that the number of clinical trial authorizations in Russia in 2016 was 3% and 8% higher than in 2015 and 2014 respectively. As a CRO, we noticed the same trend as well: the number of RFPs for international studies in Russia has been moderately but consistently increasing. As for our experience, we have never met any issues with data collected in Russia and submitted to FDA and EMA. Therefore, I believe that the most important thing here is to choose the right vendor,” says OCT President Dmitry Sharov.
More information about clinical development and drug registration services provided by OCT in Russia is available here.