Substandard Practices in Clinical Trials of Antitumor Drugs Reduced by PDCA Cycle Management
Objective To explore the applicability of PDCA cycle management in quality control of clinical trials of antitumor drugs.Methods Starting from July 2020,the PDCA cycle theory was applied to quality control of clinical trials of antitumor drugs in our hospital.The seven clinical trials of antitumor drugs completed between July 2019 and June 2020 were selected as the control group while another seven clinical trials of antitumor drugs completed between July 2020 and June 2021 served as the improvement group.The trial data was statistically analyzed to contrast not only the rate of problems related to the writ-ing of medical records involving deviations from the protocol,adverse events,drug combinations and informed consent,but also the incidence of substandard practices in clinical trials before and after the implementation of the PDCA cycle theory.Results The incidence of substandard practices in clinical trials after the implementation of the PDCA cycle theory(the improvement group)was 30.8%,much lower than 80%before the implementation(the control group),so the difference was statistically significant(P= 0.005).Conclusion The application of the PDCA cycle theory in quality control of clinical trials of antitu-mor drugs has delivered remarkable results,which helps standardize clinical trials,protect the rights and interests of subjects and improve the quality of clinical trials.
PDCA cycle managementclinical trials of antitumor drugsquality control
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