Current State and Future Trends in the Clinical Trails in General Hospital Based on Biological Products
Objective:To analyze the current situation of clinical trials of biological products,standardize clinical trial management,and provide basis for the development of clinical trials.Methods:The clinical trials carried out during 2022 are selected to analyze the clinical trials of biological products in Affiliated Hospital of Xuzhou Medical University from three aspects:professional departments,indications and adverse events.Results:A total of 135 clinical trials are carried out during 2022,with chemical drugs,biological products and traditional Chinese medicines accounting for 56.30％,41.48％and 2.22％respectively.Phase Ⅰ to Ⅳ clinical trials of biological products account for 16.07％,21.43％,60.71％and 1.79％,respectively.Among them,the departments of oncology and hematology account for 19.64％and 17.86％respectively,but the clinical trials of biological products of blood system diseases accounted for the highest proportion in China(30.95％),and the main adverse events are liver function impairment and blood cell decline,which are 11.86％and 34.02％,respectively.Conclusion:All departments should encourage the development of clinical trials of biological products represented by blood system diseases,establish and improve clinical trial management system,and ensure the smooth development of clinical trials.
NETL
NSTL
万方数据
维普
