Analysis of Reasons for Subject Screening Failures and Dropouts in Pediatric Drug Clinical Trials
Objective To provide a reference for optimizing the management of pediatric drug clinical trials.Methods The data of 25 pediatric drug clinical trials conducted by the Children's Hospital of Nanjing Medical University from January 2019 to December 2023 were collected to analyze the reasons for subject screening failures and dropouts.Results A total of 261 subjects were screened,with 63 screening failures(64 case times)and a screening failure rate of 24.14％.The reasons for screening failures included failure to meet the disease status(22 case times,34.38％),failure to meet the disease diagnosis(16 case times,25.00％),complicated with other diseases(12 case times,18.75％),withdrawal of informed consent(seven case times,10.94％),and failure to meet other requirements of the protocol(seven case times,10.94％).A total of 21 subjects were dropped out,with a dropout rate of 10.61％.The reasons for dropouts included withdrawal of informed consent(five cases,23.81％),guardian's perceived ineffectiveness(five cases,23.81％),impact of the epidemic(three cases,14.29％),occurrence of safety incidents(three cases,14.29％),failure to receive treatment after enrollment(two cases,9.52％),failure to meet the second-stage screening criteria of the protocol(two cases,9.52％),and loss to follow-up(one case,4.76％).Conclusion Failure to meet disease status,failure to meet disease diagnosis,complicated with other diseases,withdrawal of informed consent are the main reasons for screening failures in pediatric drug clinical trials.Withdrawal of informed consent,guardian's perceived ineffectiveness,impact of epidemic,and occurrence of safety incidents are the main reasons for dropouts.The optimization of clinical trial protocol design and thorough informed consent are crucial for improving the screening pass rate and dropout rate.
drug clinical trialchildsubjectscreening failuredropout
万方数据
维普
