Today we will talk about IMCTs (international multicenter clinical trials) and about the specialities of their organization and conduction in Russia. Why we need IMCTs, how they differ from “ordinary” clinical studies, what are the pros and cons are.
According to the Federal Law “On Circulation of Medicinal Products” No. 61, reports on a clinical study conducted in the form of IMCTs are accepted for the purpose of state registration of drugs if one of the centers was located in Russia. This is one of the reasons for including Russia in IMCTs. However, it’s not that simple.
In accordance with the federal law, two expert organizations decide on the possibility of conducting a CI in the Russian Federation: the Ethics Council and the Federal Center of Ecology and Emergency Management.
Due to the complexity, length and multistage of documents review while submission to the regulatory authority, our clinical centers are the last to enter into an international study.
According to the assurances of many foreign companies and CRO employees who wish to conduct clinical studies in the Russian Federation, the length of time, the inability to get a consultation from key professionals of an expert organization, regarding the quality of CI, leads to long periods for obtaining CI approval. The terms of consideration and decision-making, in accordance with the Federal Law 61, take not less than 3 months. There is no opportunity to learn about the results of these reviews, except for the applicant’s office, where the data necessary for the applicant to take operational measures are not accurately and completely reflected. In case of a negative decision, for any reason, the whole procedure starts from the very beginning.
But, despite all the peculiarities of the domestic system of admission to foreign pharmaceutical companies IMCTs, everything can be solved, companies do enter the CT (clinical trials) market. Based on the data and reviews of the AOKI and Sciencefiles, it can be concluded that the proportion of IMCTs conducted in the Russian Federation tends to decrease.
What are the goals of pharmaceutical companies in our market, why should they include the Russian Federation in their CT, considering the complexity and complete secrecy of obtaining permission for these CIs on the territory of the Russian Federation:
- Simplification of marketing authorization for a foreign company in the future. Obtaining data in their final reports, which can be presented in a package of documents, when registering a new drug in the Russian Federation. IMCTs are usually conducted in the Russian Federation in the third phase. The results of these studies allow
- Quick recruitment of trial subjects. In Russia, the researchers (doctors) are recruiting themselves, they have access and the ability to form groups of patients for the necessary research. The patients themselves often agree to participate in the study. Not because of the desire to help the company (sponsor), but because of dissatisfaction with the health care system. If there is an opportunity to get more modern diagnostics and help, for free, it enables faster and better recruitment of patients. If a study is conducted for a western company, then patients are more willing to go to such studies, even if there is any discomfort because of their normal life. Say following a specific schedule, changing the diet or other parameters. They understand that there is access to new medicines, better personal observation by a doctor.
- Obtaining and analyzing more extensive data from one territory (Caucasians, Asians, etc.). The territory of the Russian Federation is 1/6 of the land and it is inhabited by a large community of nationalities and races. The data collected in various parts of the territory may be useful and processed more quickly than individual research in Asian, European, African and other regions.
Based on the general consideration of the topic under review, IMCTs will flow to Russia, but it will not be as extensive and diverse as we would like it to be. There are both positive and negative reasons for this. We remain an interesting country with great potential and a market for IMCTs, but because of our opacity and over-regulation, most of the advantages are hidden.