现代医药卫生2024，Vol.40Issue(10)：1700-1702,3.DOI:10.3969/j.issn.1009-5519.2024.10.017
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
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分类
医药卫生引用本文复制引用
陈云艳,李晓晖,文娱..药物临床试验815例次方案违背的帕累托图分析[J].现代医药卫生,2024,40(10):1700-1702,3.
