Strategies and Practice of Standardized Application of Investigational Products Under the Normalization of Corona Virus Disease 2019 Epidemic Prevention and Control

OBJECTIVE To analyze the application of investigational products in Fujian Medical University Union Hospital under the normalization of corona virus disease 2019(COVID-19) prevention and control, to optimize existing management strategies and to provide reference for other clinical drug trial institutions. METHODS The key links and existing problems in the overall process of investigational product application were discussed and analyzed, formulating epidemic prevention and control measures and optimizing procedures. The application of investigational products, number of error events and work efficiency were compared in one year before and after optimization. RESULTS The main factors affecting the application of investigational products were personal, environmental and procedural factors. Process optimization was carried out by clarifying responsibilities, strengthening training and perfecting guidelines. After the optimization, drug clinical trial pharmacy became responsible for the drug management of 160 clinical trials in 2020, involving a total of 897 follow-up subjects, and responsible for the application of 259 kinds of investigational products. Compared with the 128 items in 2019, the work capacity continued to increase, and drug-related error events were significantly decreased(P<0.01), and work service efficiency had been effectively improved. These have received high praise from investigators, sponsors and the government regulator. CONCLUSION The COVID-19 epidemic has not had a lasting impact on the application of investigational products. The optimized procedures are used by dedicated personnel to standardize the use of investigational products under the epidemic situation, which can ensure the drug use safety on subjects and improve the quality of clinical trials.