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Clinical Trials Review in Russia (November 2020)

Data review on clinical trials in November 2020 demonstrates moderate decrease in the number of approved drug clinical trials compared with the previous month and slight increase of this number compared with the corresponding period of 2019.
Total amount of trials and the monthly average in January-November 2020 is notably lower than it was in 2016 and 2019 however it overcomes the parameters of 2017-2018. The results of the first eleven months of 2016–2019 show 827, 619, 603 and 683 clinical trials, while in 2020 the amount of trials in January-November was 661 initiations. The decrease of the total amount of trials by 3% compared with the last year should be noticed. Comparing the average number of clinical trials in January-November 2016–2020 the decrease of the parameter in 2017-2018 than it was in 2016 is clearly seen (75,2, 56,3, 54,8, 62,1 and 60,1  trials per month through 2016–2020 respectively).
The distribution by trial phase in November 2020 does not differ significantly from the previous months, bioequivalence and phase III studies traditionally prevail (45% and 30% from the total amount of trials). In November 2020 the number of under-age participants increased (11% from the total amount of trials), in previous months of the year this parameter didn’t exceed 6%. The major part of under-age participants is included in the flu vaccine trial (1326 people).
In November 2020 the increase in the number of volunteers can be clearly seen (11% from the total amount of participants), compared with the two previous months, 12000 from them (83%) are included in the research to study a vaccine to prevent COVID-19. By other criteria, November 2020 didn’t show any differences from the previous months of the year.
In November 2020 the number of initiated medical device trials increased the number of drug clinical trials by 1,5% (86 and 56 clinical trials respectively). When analyzing the parameter over the first 11 months of 2020, indicated results show prevalence in the number of medical device trials (842 and 661 trials respectively). It must be taken into account, that the amount of initiated medical device clinical trials increased towards the previous year: from 685 trials through the first 11 months of 2019 to 842 trials over the corresponding period of 2020, which means the increase approximately by 18,6% (at the same time the number of drug clinical trials decreased by 3%).