药物临床试验815例次方案违背的帕累托图分析
Pareto chart analysis of 815 cases of protocol violations in drug clinical trials
陈云艳 1李晓晖 1文娱1
作者信息
- 1. 厦门市中医院药物临床试验办公室,福建 厦门 361009
- 折叠
摘要
目的 分析药物临床试验的方案违背情况,找出需重点关注的方案违背,并提出解决方案,以保证药物临床试验质量.方法 收集2022年1-12月该院815例次药物临床试验方案违背报告数据,包括类别、例数等.采用Excel2007软件进行数据分析,绘制帕累托图,明确构成方案违背的主要因素.结果 815例次药物临床试验中药物漏服/少服/多服、检查漏查、访视超窗是方案违背的主要因素.导致方案违背的责任主体中61.84%(504/815)为受试者,25.64%(209/815)为研究者.结论 药物临床试验实施过程中,需重点关注药物服用情况,检查完整性及访视窗问题,加强研究者及受试者培训,规范药物临床试验管理,提高药物临床试验质量.
Abstract
Objective To analyze protocol violations in drug clinical trials,identify protocol violations that need to be focused on in order to propose solutions to ensure the quality of drug clinical trial.Methods A total of 815 cases of drug clinical trial protocol violation report data were collected from January to December 2022 in this hospital,including categories,number of cases,and so on.Excel2007 software was used to analyze the data,draw Pareto charts,and identify the main factors constituting protocol violations.Results Drug o-mission/underdose/overdose,examination omission,and visit over-window were the major factors for protocol violation in 815 drug clinical trials.61.84%(504/815)of the responsible subjects for protocol violations were subjects and 25.64%(209/815)were investigators.Conclusion During the implementation of drug clinical trials,emphasis need to be placed on drug use,completeness of examinations and visit window issues,and in-vestigator and paticipant training should be strengthened to standardize the management of drug clinical trials and improve the quality of drug clinical trials.
关键词
方案违背/药物临床试验/帕累托图/质量控制Key words
Protocol violations/Drug clinical trial/Pareto diagram/Quality control引用本文复制引用
出版年
2024
国家科技期刊平台
NSTL
万方数据