A Nalysis Of The Status And Countermeasures Of The Quality Control Of Drug Clinical Trials In Jiangxi Province

Objective:1.To understand the development status of drug clinical trial institutions in Jiangxi Province.2.To understand the development of drug clinical trial quality control in Jiangxi Province;3.Analyze the factors affecting the quality control of drug clinical trials in Jiangxi Province and put forward corresponding countermeasures and suggestions.Methods:Practice investigation and questionnaire survey were adopted.1.Based on the drug clinical trial institution in yi chun city people’s hospital internship experience,their participation in a number of drug clinical trials,drug clinical trial related theory knowledge,fully understand the quality control process,clinical trials in national,provincial,and organize the quality control of drug clinical trials of training in the institute,summarizes the quality control of drug clinical trials weak links,to analyze its influencing factors.2.Questionnaire survey method: in the practice process,the researchers,clinical inspectors and clinical coordinators of drug clinical trials were interviewed to deeply understand the quality control status of drug clinical trials.The questionnaire was designed based on literature,laws and regulations and practical survey results.The content of the questionnaire included two parts:basic questions and clinical trial quality control related questions.Through We Chat,questionnaires were sent to the relevant staff of drug clinical trial in Jiangxi Province,including clinical research doctors,clinical research pharmacists,clinical research nurses,clinical coordinators and clinical monitors,etc.,and the questionnaires were collected for SPSS and Excel data analysis.RESULTS:By sorting out and comparing the laws and regulations related to drug clinical trials at home and abroad,it was found that the laws and regulations of drug clinical trials in China were gradually improved.The promulgation of the new version of the Good Practice for Quality Management of Drug Clinical Trials in 2019 marked a new step for drug clinical trials in China.The quality control level of drug clinical trial has also been improved,but some aspects still need to be strengthened.By summarizing the recent studies on the quality control of drug clinical trial conducted by researchers in China,and through questionnaire research and interviews with drug clinical trial staff,the following conclusions can be drawn:There was a significant difference in the knowledge of laws,regulations and SOP(P < 0.05),indicating that the staff participating in the training of quality control of drug clinical trials had a better understanding of relevant laws,regulations and SOP.Using factor analysis to questionnaire item is divided into eight dimensions,respectively affect drug clinical trial eight factors on the effectiveness of the quality control,familiar with laws and regulations,SOP,informed consent,adherence test,experiment data records,test data management,data outliers,adverse event processing,medicine,management,There was significant correlation among the 8 influencing factors(P< 0.05),and the correlation values were all greater than 0.A total of 8influencing factors were positively correlated.CONCLUSIONS:The main factors affecting the quality control effect of drug clinical trial are summarized as follows: the familiarity of laws,regulations and SOP;Informed consent;Test compliance;Experimental data recording;Data management;Outlier processing;Adverse event management;Drug administration.In view of the factors that affect the quality control effect of drug clinical trial,we put forward some suggestions to improve the quality control level of drug clinical trial in Jiangxi Province and ensure the scientificity of clinical trial: improve laws and regulations,SOP training system,strengthen the basic theory of researchers;Establish archives management system and increase supporting hardware facilities;Improve the compliance of the test process and protect the legitimate rights and interests of the subjects;Rigorously treat the test data to ensure authenticity and accuracy;Properly handle data outliers and adverse events;Improve the management system of experimental drugs;Establish effective supervision system,strengthen the consciousness of quality control construction;Combine electronic information system to ensure quality control.