摘要
目的通过分析呼吸专业临床试验方案偏离或违背的原因及特点,探讨预防或减少方案偏离或违背的方法,为保证临床试验质量和制定相关的预防策略提供依据。方法通过临床试验信息管理系统收集2018年1月1日-2023年6月30日某院呼吸专业开展的35个临床试验项目,共纳入受试者635例,将收集的资料进行整理并录入Excel表格中,记录方案偏离或违背事件的发生次数,根据相关事件发生类型、对受试者和试验造成的影响进行分类统计分析。结果35个项目共计发生481例次方案偏离或违背。其中,访视超窗、缺失158例次,占32.85%;试验药物相关偏离或违背137例次,占28.48%;检查、检验相关偏离或违背61例次,占12.68%;流程错误51例次,占10.60%;违反入选排除标准42例次,占8.73%;未按规定收集信息29例次,占6.03%;其他3例次,占0.62%。结论开展临床试验过程中,通过优化方案,加强研究者培训深度,让受试者充分知情等措施可有效减少方案偏离或违背,为不断提高临床试验质量提供借鉴。
Objectives Through analyzing the reasons and characteristics of deviation/violation of clinical trial protocols in respiratory specialties,this study explored how to prevent or reduce the occurrence of protocol deviation/violation,and provided a basis for ensuring the quality of clinical trials and formulating relevant prevention strategies.Methods Through the clinical trial information management system,35 clinical trials conducted by the respiratory specialty of a hospital from January 1st,2018 to June 30th,2023 were collected.A total of 635 subjects were included.The collected data were organized and entered into an Excel spreadsheet,and the number of protocol deviations/violations was recorded.Based on the type of relevant events and the impact on the subjects and the trial,a statistical analysis was conducted.Results A total of 481 cases of deviation/violation of the plan occurred in 35projects.Among them,there were 158 cases(32.85%)of missing visits to the super-window,137cases(28.48%)of deviations/violations related to the test drug,61 cases(12.68%)of deviations/violations related to inspection and testing,51 cases(10.60%)of process errors,42 cases(8.73%)of violations of inclusion and exclusion criteria,29 cases(6.03%)of information not collected as required,and 3 cases(0.62%)of other reasons.Conclusions In the process of conducting clinical trials,measures such as optimizing the protocol,strengthening the depth of researcher training,and ensuring that subjects were fully informed could effectively reduce protocol deviations/violations,provide reference for continuously improving the quality of clinical trials.
作者
权京玉
林英翔
王淑芹
Quan Jingyu;Lin Yingxiang;Wang Shuqin(Department of Respiratory and Critical Care Medicine,Beijing Chaoyang Hospital Affiliated to Capital Medical University,Beijing 100102,China;不详)
出处
《中国病案》
2024年第12期106-109,共4页
Chinese Medical Record
基金
北京市科学技术委员会基金(Z201100005520031)。
关键词
方案偏离
方案违背
临床试验
研究者
预防策略
Deviation from the plan
Plan violation
Clinical trials
Researchers
Preventive strategies
