Organizing the large multiple-center clinical trials based on modern digital approaches during the pandemic of a novel coronavirus infection in Moscow

Abstract

Objective. To assess the effectivenes of the technologies aimed at the accelerated organisation and improved quality of the Gam-Covid-Vac Vaccine clinical trial in the Moscow healthcare institutions. Material and methods. The organizational structure of the research support and its resource support were described and analyzed. The study investigated regulatory documents issued by the Moscow Healthcare Department, primary medical records in line with the study protocol uploaded to the Unified Medical Information and Analytical System (EMIAS), electronic diaries of study participants, training programs for research teams, and the organization of their training. Results. The clinical trial was conducted collectively by 30 organizations, including 21 medical institutions. More than 400 physicians, including 79 physicians of telemedicine center, 185 nurses and 163 clinical monitors were involved. Online learning enabled to quickly educate the needed amount of clinical investigators. The organization model of research centers’ activity along with the combination of face-to-face visits and remote patient monitoring allowed to recruit volunteers, to observe them according to the protocol and to ensure their safety. The collection of primary medical data was integrated into EMIAS. It helped to receive the traceable and reliable data about volunteers’ health status and to monitor adverse events. All laboratory tests were carried out using the equipment and the reagents of one manufacturer. Because the central laboratory unified all study methodologies in a short period of time (less than 24 hours), the study results were recorded in the EMIAS-integrated information system. The vaccine was — delivered within a continuous cold chain supply using multi-level monitoring of test product storage temperature. Conclusions. The algorithm for improving quality and accelerating the clinical trial process of the Gam-COVID-Vac vaccine was developed, implemented, and put into action, driven by the capacities of the Moscow healthcare system, the electronic primary health records, the telemedicine system, a highly equipped central clinical laboratory, the ability to engage any medical experts, and the coordination and cooperation system of institutions. Moscow healthcare organizations could serve as a platform for large-scale clinical trials.

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