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Clinical Trials Review in Russia (February 2018)

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

The data analysis revealed that both ongoing and average monthly number of trials over the last two months was inferior opposed to the corresponding period of 2017. Over the last three years, there was a gradual decrease in the number of approved ongoing trials over the first two months (in January-February 2017, the number of approved trials declined by 22%, while in the corresponding period of 2018 – by 37% compared with January-February 2016).

The distribution by trial phase, in principle, did not show any significant differences from the general trend over the previous months, with predominance of the phase III trials and bioequivalence studies, however unlike the previous month of 2018, the proportion of the phase III trials increased in February and accounted for 49% of all initiated trials (opposed to January 2018 - 26%). By other parameters, February 2018 did not differ significantly from the previous months.

In February 2018, the number of initiated medical device clinical trials exceeded the number of drug clinical trials more than 1.5 times (90 vs 57 trials, respectively). When analyzing the parameter over the first two months of 2018, the prevalence in the number of medical device trials over the drug trials (152 vs 92 trials, respectively) was clearly seen. It should be noticed that the number of initiated medical device trials decreased in comparison with the previous year: from 164 trials over the first two months of 2017 to 152 trials over the corresponding period of 2018, so there was a decline by approximately 7.5%, whereas the number of drug clinical drug declined by 19% over the corresponding period.