药物临床试验伦理委员会安全性审查现状与分析OA

Objective To investigate the current status of safety review by institutional review boards(IRBs)for clinical drug trials in China,analyze existing issues and needs for improvement,and provide a basis for enhancing the quality and efficiency of ethical review.Methods An online questionnaire survey was conducted from May 2025 to March 2026,targeting 391 IRBs for clinical drug trials across 29 provinces,municipalities,and autonomous regions nationwide.The questionnaire covered the basic profile of the ethics committees,requirements for submitting safety reports and review processes,as well as attitudes toward the need for improvements in the review process.SPSS AU was used to perform descriptive statistics,analysis of variance(ANOVA),correlation analysis,and post-hoc analysis.The results showed that the questionnaire had good reliability and validity(Cronbach's α=0.932,KMO=0.946).Results 86.7％of the drug clinical trial ethics committees explicitly stipulated in their SOPs the selection criteria and decision-makers for the review method of safety reports;however,implementation was inconsistent at critical stages,with a portion(46.04％)of the committees not having the chairperson decide on the selection of the lead reviewer.Regarding serious adverse events(SAEs),94.63％of drug clinical trial ethics committees required the principal investigator to submit reports;however,there were discrepancies in the interpretation of the provisions of the"Good Clinical Practice for Drug Clinical Trials"(2020)(48.85％believed that only suspected and unexpected adverse reactions needed to be reviewed).59.34％of ethics committees updated the types of review conclusions in a timely manner to be consistent with the"Measures for Ethical Review of Life Sciences and Medical Research Involving Humans"(2023).The results showed that there was no significant difference in the recognition of all improvement suggestions among the levels of different health institutions,investigators' working years,professional backgrounds and technical titles,proving that the industry has a common and consistent demand for improving ethical standardization review.Correlation analysis shows that various improvement measures are closely related.Among them,the"Standard Operating Procedures for the Establishment and Review of Ethics Committees"and the"Application Guidelines for Institutional Establishment"showed a strong positive correlation(r=0.716,P＜0.01),and various measures were positively correlated with"supervision by superior authorities"(r=0.407～0.705,P＜0.01),highlighting the need for systematic optimization.Conclusion Our country's ethical review system for drug clinical trial safety reports has been initially established,but it needs to be strengthened in terms of uniformity of review standards,timely implementation of regulations and standardization of process operations.This survey results show that in the future,efforts should be made to build a four-in-one systematic optimization plan of"regulations-standards-capabilities-supervision"to unify industry standards,improve review efficiency,and effectively protect the rights and interests of research participants.