Open AccessRegulatory aspects of clinical trials in case of emergency
Author(s) -
A. V. Rodina
Publication year - 2022
Publication title -
vestnik universiteta imeni o.e. kutafina (mgûa)/vestnik universiteta imeni o. e. kutafina
Language(s) - English
Resource type - Journals
eISSN - 2782-6163
pISSN - 2311-5998
DOI - 10.17803/2311-5998.2021.87.11.168-174
Subject(s) - clinical trial , medicine , product (mathematics) , pandemic , intensive care medicine , covid-19 , medical emergency , disease , pathology , geometry , mathematics , infectious disease (medical specialty)
The article deals with aprocedure of clinical trial of medical product for human use and describes regulatory aspects of а clinical trial in case of emergency, including the COVID-19 pandemic, analyses the grounds and conditions of studding properties of medical product, passed the state registration, for off-label use, without post-marketing clinical trial (low-interventional study). An assessment is made of the streamlined procedure of the registration of medical products, referring for the prophylactic and treatment of the diseases incase of emergency, andit is concluded about necessity ofextension this proceduretomedical products, which can be used for the treatment of other types of diseases.