Analysis and Intervention on the Key Links of the Quality of Drug Clinical Trials in Our Hospital / 中国药房

ABSTRACT

OBJECTIVE:To discuss the countermeasure on the quality improvement of the drug clinical trials in our hospital based on the discovery of key links of the quality of clinical trials. METHODS:Quality results of 14 drug clinical trials in 10 ma-jors from the drug clinical trial institute in our hospital in 2014 were investigated. Referring to the grading and classifying methods of the inspection problems in European Medicines Agency,the key links of occurring problems were analyzed,and the effects of interventions for key links were evaluated. RESULTS:In 2014,totally 125 important and general problems were found,in which, the numbers of problems occurred in case report form filling,informed consent of subjects,enrolling and screening of subjects,in-vestigational products management accounted for 79.20%. The above 4 links were the key links affecting quality of drug clinical tri-als. According to strengthening the training about relevant knowledge of the researchers,improving system and standard operation procedures management,enhancing link quality control,introducing project clinical research coordinator,developing centralized drug management and other interventions,the total numbers of found important and general problems in 2015 and 2016 were 68 and 59,respectively. Compared with 2014,the differences were statistically significant(P0.05). There were no severe problems during 2014-2016. After interventions,numbers of occurring prob-lems in majors with less complex drug clinical trial had obviously declined in 2016. Compared with 2014,the differences were sta-tistically significant (P0.05). CONCLUSIONS:Controlling the key links in drug clinical trial process can obviously reduce the occurrence of general problems while has little effect on the occurrence of im-portant problems. It is different for different majors in undertaking drug clinical trial projects,so as the links and degree of occur-ring problems. It should be distinguished in quality control checking.