Application of PDCA cycle method in improving the quality management of drug clinical trials / 中华医学科研管理杂志

ABSTRACT

Objective:To strengthen the quality management of drug clinical trials to ensure that the clinical trial data obtained is true, accurate, complete and standardized.Methods:By review literatures and the data published in NMPA and survey the problems in the drug clinical trials in some hospitals, etc, we summarized the common problems of drug clinical trials in China.At the same time, using PDCA cycle theory, we sorted out the problems in the drug clinical trials in Taizhou People's Hospital, conducted root-cause analysis of the problems, put forward suggestions and measures on how to strengthen the quality management of drug clinical trials.Results:The incidence of quality problems in clinical trials was significantly reduced from 105.6% to 37.4% by formulating relevant incentive policies, strengthening training, strengthening the supervision function of institutions to researchers, and improving the awareness of GCP of researchers.Conclusions:The implementation of PDCA cycle quality management model can effectively improve the quality of drug clinical trials.