Rakova announced the ecosystem of clinical trials of drugs created in Moscow

Anastasia RakovaAnastasia RakovaAnastasia RakovaAnastasia RakovaAnastasia Rakova

An ecosystem has been formed in the capital for conducting clinical trials of drugs with a single communication center, said Anastasia Rakova, Moscow Deputy Mayor for Social Development. This helps pharmaceutical companies gain access to the entire metropolitan medical infrastructure.

According to the Vice Mayor, in this way the city supports the pharmaceutical industry in the face of sanctions pressure and seeks to establish import substitution in order to fully provide residents with all the necessary medicines.

Rakova clarified that within the ecosystem, pharmaceutical companies have the opportunity to choose a center for research from almost 90 hospitals and clinics, which employ more than 7 thousand qualified specialists with GCP certificates (Good Clinical Practice, an international ethical and scientific standard for planning and conducting research). Thus, 80 therapeutic directions are available for conducting clinical trials of drugs. In addition, it provides for the availability of laboratories that can be converted into a centralized laboratory for conducting multicenter research , local ethics committees and the Moscow City Independent Ethics Committee, as well as a telemedicine center that allows remote monitoring of volunteers.

“The main thing is that we have a single digital circuit between all city medical organizations, which ensures the quality and safety of the study, allows doctors to have access to all information about the patient, if necessary, pre-form a database of patients who can potentially become volunteers according to the specified criteria,” — emphasized the deputy mayor.

According to Rakova, the Moscow Center for Innovative Technologies in Healthcare is the key communication center in this system. It helps all parts of the system to work "seamlessly", as a single organism. Such an ecosystem allows pharmaceutical companies to launch clinical trials as soon as possible, while companies can receive both organizational and financial support from the city authorities.

One of the clearest examples of the organization of the work of the Moscow ecosystem is the speed of recruiting and conducting a clinical trial of the Sputnik V vaccine against covid-19 . Thanks to well-coordinated work, in just 3.5 months, the capital conducted a preliminary examination (screening) of more than 113 thousand people and included more than 33 thousand volunteers in the study.

The Vice Mayor added that since last September, seven pharmaceutical companies have applied for help from the city in conducting clinical trials, which are conducting a total of 16 trials.

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According to Rakova, a single digital circuit not only ensures the smooth operation of the entire ecosystem, but also provides unique opportunities. “For example, with the help of the Unified Digital Platform, with the consent of a volunteer, we can show all our medical organizations (clinics, hospitals, ambulances) that a person, having turned to them for help, is a participant in a clinical trial. This will help doctors during the examination to pay attention to important aspects and, if necessary, contact the research center, ”she said.

“The unified digital platform of Moscow healthcare enables quick and high-quality selection of patients suitable for inclusion in the study, as well as more effective monitoring of their HEALTH, including using telemedicine technologies,” adds the chief freelance specialist in adult primary health care Andrey Tyazhelnikov to the population of the Moscow Department of Health.

In Moscow, the operation of the program of comprehensive support for conducting clinical trials of new drugs on the basis of city medical institutions last December was extended by Moscow Mayor Sergei Sobyanin . The program includes both organizational assistance (selection of city medical organizations for research, volunteers, assistance in the formation of a research team, legal support), and financial assistance for drugs that are of particular importance for the capital's healthcare.

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