MOSCOW, May 10. Moscow has formed an ecosystem for conducting clinical trials of medicines with a single communication center, which, when applied by pharmaceutical companies, helps with access to the entire capital's medical infrastructure, said Anastasia Rakova, Deputy Moscow Mayor for Social Development.
“In the context of external sanctions pressure, we pay great attention to supporting the pharmaceutical industry. Our task is to establish import substitution and fully provide residents with all the necessary medicines. to choose a center for research from almost 90 hospitals and polyclinics, which employ more than 7 thousand qualified specialists with GCP certificates, in 80 therapeutic areas and in all phases of research, with more than 15 years of experience,” explained Rakova, whose words are quoted on portal of the Mayor and the Government of Moscow.
In addition, she noted that there are laboratories that have the opportunity to become a centralized laboratory in the event of a multicenter study, local ethics committees and the Moscow City Independent Ethics Committee, as well as a telemedicine center that allows remote conduct supervision of volunteers.
“And, most importantly, we have a single digital circuit between all city medical organizations, which ensures the quality and safety of research, allows doctors to have access to all information about the patient, if necessary, pre-form a base of patients according to specified criteria who can potentially become volunteers «The key center of communication in this system is the Moscow Center for Innovative Technologies in Healthcare. It helps all parts of the system work «seamlessly», as a single organism. Such an ecosystem allows pharmaceutical companies to launch clinical trials as soon as possible, and we are ready to provide companies with both organizational and and financial support,» the Vice Mayor said.
One of the brightest examples of the work of the Moscow ecosystem, Rakova called the clinical trial of the Sputnik V vaccine. 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 study was conducted on the basis of 22 medical organizations and was completely digital. en/20230502/zdorovaya-moskva-1869092324.html» data-title='Healthy Moscow pavilions to open in Moscow parks in mid-May'>
The vice mayor added that since September 2022, 7 pharmaceutical companies have applied for help from the city in conducting clinical trials, which are conducting a total of 16 trials. According to 9 studies, research centers have already been selected based on Moscow hospitals and polyclinics, and 4 — in the process of selecting centers. For one study, assistance was provided in the recruitment of volunteers, for two, patient databases were prepared with the aim of further assistance in recruitment. 2 pharmaceutical companies applied for financial support for 10 trials.
Also, Moscow has developed a system of training and advanced training for research teams working in the network of metropolitan hospitals and polyclinics. Specialists can obtain the necessary knowledge to obtain GCP certificates (Good Clinical Practice, the international ethical and scientific standard for planning and conducting research). The Moscow Research School also hosts monthly seminars with leading experts in clinical research. In addition, the developed standards of operating procedures for all stages of research are posted on the online platform for research centers.