Analysis of the causes of deviation of clinical trial protocol of anti-tumor drugs and discussion of management countermeasures
Objective To analyze the causes of protocol deviation in clinical trial of anti-tumor drugs,and to explore the corresponding management countermeasures.Methods A total of 560 drug clinical trials conducted in the Affiliated Hospital of Xuzhou Medical University from January 2021 to October 2023 were selected,and the causes of protocol deviation in clinical trials of anti-tumor drugs were retrospectively analyzed,and corresponding management countermeasures were formulated according to possible reasons.Results Among 560 clinical trials,231 cases(41.25%)were protocols deviation of anti-tumor drugs clinical trials,.The top three reasons were:Non-compliance with(SOP)(31.60%,),over-window of inspection methods and evaluation(27.27%),non-compliance with the usage and dosage of anti-tumor drugs(18.61%).Among the harm of anti-tumor drug clinical trial deviation from the protocol,65.80%of the trials had continued violation of the protocol,which was not a major protocol violation,but repeated and multiple violations;26.84%of the trials did not correct the violation events.In comprehensive assessment,there were 28 A-level risks(12.12%,requiring using corresponding measures and continuous attention),140 B-level risks(60.61%,requiring close attention),and 63 C-level risks(27.27%,the risks were controllable range).Conclusion In clinical trials of anti-tumor drugs,non-compliance with SOP,over-window of inspection methods and evaluation,and non-compliance with the usage and dosage of anti-tumor drugs are the main reasons leading to the deviation of the program.The subjects of the deviation include sponsors,researchers,subjects,etc.,and it has many harms.Relevant departments should pay attention to the deviation and dynamically monitor the risk grade orientation of the project,and mprove the rationality of the use of antitumor drugs.
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