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Clinical Trials in Russia (August 2017)

Data analysis for August 2017 showed a small decrease in the number of approved clinical trials compared with the last month and the minimum number of studies compared with the same period in 2013-2016. The ongoing and monthly average number of clinical trials for August 2017 decreased significantly, compared to the same in 2016 and lower of indicators for 2014-2015. The first 8 months of 2013-2015 yield is: 541, 491 and 471 trials; the number of trials during Jan-Aug in 2016-2017 is 614 and 466 correspondingly.

There is about 1% decrease in number of trials compared with 2015, and 24% compared with 2016. When comparing the average number of clinical trials for January-August 2013-2017, the decrease of the indicator is also clearly seen, with its sharp increase in 2016 with respect to 2013-2015 (67.6, 61.4, 58.9, 76.8 and 58.3 trials per month for 2013–2017 correspondingly). Thus, the difference between the periods 2013-2015 and 2017 is about 10 studies per month in assessing the first 8 months of each year. In 2017 is the lowest indicator, and in 2016 – the highest indicator for the periods of 2013-2017.

The first 8 months of 2017 also show some predominance of medical device trials (642 and 466 trials). The number of new medical device for clinical trials decreased dramatically compared with last year: from 782 trials during the first 8 months of 2016 to 642 trials during the same period in 2017; i.e. there is about a 18% decrement (for the number of drug clinical trials - a 24% increment occurred).