Problems faced in the operation of clinical trials for diseases involving fever during the regular COVID-19 prevention and control period and countermeasures.

ABSTRACT

During the regular COVID-19 prevention and control period, the running of fever-related clinical trial projects faces many problems, which will affect the development of new drugs. How to coordinate the regular COVID-19 prevention and control with the clinical trial process is the key to ensure that the clinical trial participants are successfully enrolled. In this paper, taking the influenza project as an example, combined with the practice of operation and management of the influenza clinical trial project in our hospital, the problems faced in the operation of fever-related clinical trial projects during the regular COVID-19 prevention and control period were discussed and the countermeasures and suggestions were proposed. In order to meet the dual needs of infectious disease prevention and control and clinical trials, it is recommended that in low-risk areas for COVID-19, the subject screening process be integrated with the COVID-19 exclusion process, the starting time of subject screening be moved forward, clinical trial enrollment be conducted while waiting for COVID-19 screening results, in addition, the clinical trial process after COVID-19 screening results are returned should be established in advance. Copyright © 2022, Chinese Journal of New Drugs Co. Ltd. All right reserved.