药物临床试验前置伦理审查实践回顾与思考OA

Objective:To sort out the pre-ethical review status of drug clinical trials in a tertiary A hospital,summarize practical experience,and provide references for pre-ethical review.Method:A retrospective analysis was conducted on the ethical review of pre-ethical projects in a tertiary A hospital from 2018 to 2023.Results:From 2018 to 2023,a total of 285 pre-ethical projects were reviewed in this tertiary hospital,including 79 projects where it served as the leading unit.Among these,279 clinical trials ultimately received approval of the ethical review committee,while 6 projects were not approved due to sponsors'refusal to modify study protocols.In terms of trial phases,phase III clinical trials constituted the largest proportion,and the oncology center was the department with the highest number of projects.In 2023,the average time for pre-ethical review projects from submission to approval was 43 calendar days,3 days longer than for other project types.In 2023,this hospital reviewed 75 pre-ethical review projects,including 58 where it served as a participating unit.Among these,42 projects received approval later than the leading unit,while 9 projects were approved earlier than the leading unit's ethical approval date.Among the pre-ethical review projects applied in 2023,70 projects obtained drug clinical trial notifications from the National Medical Products Administration,while 5 projects had unknown notification status due to the lack of ethical approval or discontinuation.Of the projects receiving approval notifications,16 were annotated with matters requiring enhanced attention during clinical trials,and 7 necessitated protocol improvements.Conclusion:This tertiary A hospital has implemented multiple measures to optimize the management of pre-ethical review.This ethical review model does not compromise the quality of ethical review and contributes to accelerating the initiation of clinical trials.Notably,it is crucial to construct a patient-centered drug development system.Clinical trials guided by this concept align with ethical values,laying the foundation for the smooth conduct of clinical trials,assisting in the drug development process,and safeguarding patients'medication needs.