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Clinical Trials Review in Russia (March 2018)

Data review on clinical trials in March 2018 showed a slight increase in the number of approved drug trials compared with the previous month and a slight decrease in the number of clinical trials compared with the corresponding period of 2017.

Overall results, both ongoing and average monthly number of trials over the first three months of 2018 were much inferior to the corresponding period of 2017. The number of approved trials over the analyzed period (January – March) had a tendency to decrease over the last three years (in January – March 2017, the number of approved trials was 20% less by contrast with the corresponding period of 2016, while in January – March 2018 it was even 32% lower). Analyzing the data from 2013 to 2018, one might reveal that the data of 2018 was very close to those of 2015.

The distribution by trial phase in March 2018, appeared to be very close to the previous months of the year with the prevalence of phase III trials and bioequivalence studies. As opposed to the previous months, the number of clinical trial participants increased while the ratio between the volunteers and patients recruited remained at the same level.

In March 2018, the number of initiated medical device clinical trials exceeded the number of drug trials insignificantly in comparison with the previous months of 2018 (66 and 59 trials, respectively). However, when analyzing the data over the first three months of 2018, the number of medical device trials clearly predominated over the number of drug trials (218 and 151 trials, respectively). Analyzing the number of approved clinical trials over the first three months of the year from 2015 to 2018, it might be noted that the number of initiated medical device trials gradually decreased: from 304 trials over the first three months of 2015 to 218 trials over the corresponding period of 2018, so the number declined by about 30%.