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Clinical Trials Review in Russia (October 2020)

Data review on clinical trials in October 2020 demonstrates slight decrease in the number of approved drug clinical trials compared with the previous month and remains unchanged compared with the corresponding period of 2019.      
Total amount of trials and the monthly average in September 2020 have the same tendency – the indications of 2020 are close to the ones 2017-2018 but visibly lower that the ones of 2016 and 2016 in particular.
The results of the first ten months of 2016–2019 show 760, 573, 551 and 631 clinical trials, while in 2020 the amount of trials in January-October was 605 initiations. Decrease of the total amount of trials by 4% compared with the last year should and increase by 12% compared with 2018 should be noticed. Comparing the average number of clinical trials in January-October 2016–2020 increase of the parameter in 2019 after its sharp drop in 2017 compared with 2016 (76, 57,3, 55,1, 63,1 and 60,5 trials per month through 2016–2020 respectively).
The distribution by trial phase in October 2020 does not differ significantly from the previous months, bioequivalence and phase III studies prevail. At the same time in October 2020 the part of patients participating comes to 89% among others. In previous months of 2020 this parameter didn’t exceed 86%. By other criteria, October 2020 displays the same characteristics as the previous months of the year.
In October 2020 the number of initiated medical device trials increased the number of drug clinical trials in 1,4 times (90 and 66 clinical trials respectively). When analyzing the parameter over the first ten months of 2020, indicated results show prevalence in the number of medical device trials (756 and 605 trials respectively). It must be taken into account, that the amount of initiated medical device clinical trials increased towards the previous year: from 633 trials through the first ten months of 2019 to 756 trials over the corresponding period of 2020, which means increase approximately by 16% (at the same time the number of drug clinical trials decreased by 4%).