Analysis on Reasons for Deviation/Violation of Clinical Trial Plans in Respiratory Specialty and Preventive Strategies
Objectives Through analyzing the reasons and characteristics of deviation/violation of clinical trial protocols in respiratory specialties,this study explored how to prevent or reduce the occurrence of protocol deviation/violation,and provided a basis for ensuring the quality of clinical trials and formulating relevant prevention strategies.Methods Through the clinical trial information management system,35 clinical trials conducted by the respiratory specialty of a hospital from January 1st,2018 to June 30th,2023 were collected.A total of 635 subjects were included.The collected data were organized and entered into an Excel spreadsheet,and the number of protocol deviations/violations was recorded.Based on the type of relevant events and the impact on the subjects and the trial,a statistical analysis was conducted.Results A total of 481 cases of deviation/violation of the plan occurred in 35 projects.Among them,there were 158 cases(32.85%)of missing visits to the super-window,137 cases(28.48%)of deviations/violations related to the test drug,61 cases(12.68%)of deviations/violations related to inspection and testing,51 cases(10.60%)of process errors,42 cases(8.73%)of violations of inclusion and exclusion criteria,29 cases(6.03%)of information not collected as required,and 3 cases(0.62%)of other reasons.Conclusions In the process of conducting clinical trials,measures such as optimizing the protocol,strengthening the depth of researcher training,and ensuring that subjects were fully informed could effectively reduce protocol deviations/violations,provide reference for continuously improving the quality of clinical trials.
Deviation from the planPlan violationClinical trialsResearchersPreventive strategies
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