Analysis and management of non-compliance/protocol violation or deviation during clinical trials / 中华医学科研管理杂志

ABSTRACT

Objective:To collect and analyze the non-compliance/protocol violation or deviation reported to the hospital Ethics Committee from 2017 to 2019, to explore the pattern of such events, as well as the causes and related logic. Empirical data evidence, lessons learned and preliminary advice were proposed to improve the understandings, management and implementation of clinical trials regarding to the non-compliance/protocol violation or deviations.Methods:The chi-square test and non-parameter test were conducted using SPSS 22.0.A total number of 754 reports received were analyzed, compared and summarized to provide the preliminary advice.Results:From 2017 to 2019, 754 reports on non-compliance/protocol violation or deviation, which covered 219 projects from 29 clinical departments, were received. 88% of these projects were drug/medical device clinical trials, while other 12% were investigator initiated trials. The reportrd events could be divided into 7 categories. The distribution of project resources, trial types and clinical specialties are significantly different. Meanwhile, the reports submitted by investigators have a lot of space for improvement.Conclusions:There were significant differences in the type and number of reported events on non-compliance/protocol violation or deviation between different trial types, as well as clinical trial specialties. The application report of protocol violation is generally poor. Combined with the working practice, the common reasons for the protocol violation are " the low overall compliance of the subjects" and " the insufficient compliance of the researchers" . Preliminary suggestions for management reform, such as increasing the training for researchers, improving the reporting mode, and regularly issuing follow-up and review research reports are recommended.