Russian FederationThere are number of advantages for clinical trials in Russia:
- Full compliance with the international standards of ICH GCP (Good Clinical Practice).
- Detailed documentation and a focus on accountability and quality indicators allow to obtain data of the highest accuracy.
- Analysis of the results of regulatory inspections including representatives of the regulator of the EU and the US, indicates a significantly smaller proportion of critical findings in comparison with other regions. For the period from 19951 to 2016 67% of clinical research in the Russian Federation have been no complaints from the FDA. Data calculations is based on the relationship of NAI (No Action Indicated)2 to the number of inspections performed by the FDA3.
- A large population. Population on 1 January 2017 is 146 838 993 people.
- A relationship of trust between doctors and patients contribute to the rapid recruitment in clinical research, as well as retention of patients in a clinical trial.
- High prevalence of chronic diseases and cancer, which also increases the speed of recruitment and the insertion in clinical studies patients without prior treatment and with different degrees of severity of the process.
- The majority of the population is Caucasian, which makes the results easily generalize, and the unique diversity of genotypes increases the attractiveness for research in oncology and immunology.
- When conducting clinical research with the participation of the Russian population of patients the need for local clinical trials is abolished.
- Legislation and the system of organization of clinical research in the Russian Federation also make it extremely attractive for clinical research. Term of authorization for conducting clinical studies is up to 40 working days.
- The registration`s duration is up to 160 calendar days from the date of acceptance of the application for state registration prior to the issuance of the registration certificate.
- Cost of state registration of medicines (excluding the cost of conducting a clinical study) is much lower than in the US and Europe, about 9,305 U.S. dollars.
- There is a tendency to increase the number of permits issued for the conduct of clinical trials – overall by 30% in comparison with the previous analogous period.
- The potential to reduce the budget of the clinical trial.
- The presence of all TOP 10 pharmaceutical companies in the Russian Federation.
- In the middle of 2017 year, it is planned to release a single for all state members of The Eurasian economic community of the document on the procedure for the authorization of clinical trials that will make the procedure uniform for all States parties.
2Read more about classification of violations here.
3Read more about the number of inspections performed by the FDA here.