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Clinical Trials Review in Russia (December 2020)

Data review on clinical trials in December 2020 demonstrates increase in the number of approved drug clinical trials compared with the previous month and also with the corresponding period of 2019.      
Total amount of trials and the monthly average is notably lower than it was in 2016 and 2019 however it overcomes the parameters of 2017-2018. The results of of 2016–2019 show 898, 700, 653 and 746 clinical trials, while in 2020 the amount of trials was 734 initiations. Increase of the total amount of trials by 11% compared with 2018 and decrease of the total amount of approved trials by 1,6% during the last year should be noticed. Comparing the average number of clinical trials in 2016–2020 the decrease of the parameter in 2017-2018 than it was in 2016 is clearly seen (74,8, 58,3, 54,4, 62,2 and 61,2 trials per month through 2016–2020 respectively).
The distribution by trial phase in December 2020 does not differ significantly from the previous months, bioequivalence and phase III studies traditionally prevail (26 approved trials). In December 2020 the number of patients increased (65% from the total amount of trials), also the part of under-age participants can be noticed (17%). By other criteria, December 2020 didn’t show any differences from the previous months of the year.
In December 2020 8 clinical trials of a vaccine to prevent COVID-19 were approved, that is 4 trials more than it was in November 2020.
In December 2020 the number of initiated medical device trials increased the number of drug clinical trials by 1,25 times (70 and 56 clinical trials respectively). When analyzing the parameter over the 12 months of 2020, indicated results show prevalence in the number of medical device trials (898 and 734 trials respectively). It must be taken into account, that the amount of initiated medical device clinical trials increased towards the previous year: from 799 trials in 2019 to 898 trials over the corresponding period of 2020, which means the increase approximately by 11% (at the same time the number of drug clinical trials decreased by 1,6%).