摘要
目的为降低方案偏离的发生率,提高临床试验质量,探讨临床试验研究者管理体系的建设。方法通过在中国知网、万方数据知识服务平台和维普网数据库检索临床试验实施过程中发生方案偏离的文献报道,检索时间为建库以来至2023年1月5日,提取文献中方案偏离的数据,并对方案偏离问题进行归类分析,进一步提出处理措施以降低方案偏离的发生率。结果共检索出文献122篇,最终纳入11篇符合纳入/排除标准的文献,均为中文。临床试验方案偏离问题89个,根据方案偏离的类别归类为8大类,其中方案偏离发生例次及发生率排在前3位的问题类别为试验程序问题(6264例次,58.72%)、试验用药品的管理与使用问题(1594例次,14.94%)、纳入/排除标准方面的问题(1362例次,12.77%)。结论通过建立研究者管理体系,规范对研究者的管理,降低方案偏离的发生率,提高研究者的临床研究水平,保障受试者的安全和权益,提高临床试验质量。
Objective To discuss the construction of management system for clinical trial investigators,in order to reduce the incidence of protocol deviation and improve the quality of clinical trials.Methods By searching the reports about protocol deviation in the process of clinical trial implementation in China National Knowledge Network(CNKI),Wanfang data knowledge service platform,and VIP database till January 5,2023,the data of protocol deviation were extracted,the deviation problems were classified and analyzed,and the treatment measures were tailored to reduce the incidence of protocol deviation.Results A total of 122 literatures were retrieved,and 11 literatures meeting the inclusion/exclusion criteria were finally included,all of which were in Chinese.There were 89 clinical trial protocol deviation problems,which were classified into 8 categories according to the category of protocol deviation.Among them,the top 3 categories of problems with protocol deviation occurrence and incidence were experimental procedures(6264 cases,58.72%),management and use of investigational product(IP)(1594 cases,14.94%),and inclusion/exclusion criteria(1,362 cases,12.77%).Conclusion By establishing the investigator management system,we can standardize the management for investigators,reduce the incidence of protocol deviation,improve the investigators'clinical research level,ensure the subjects'safety and interests,and assure the quality of clinical trials.
作者
胡志琴
郑思超
汪小乐
王腾华
方翼
李咏梅
Hu Zhiqin;Zheng Sichao;Wang Xiaole;Wang Tenghua;Fang Yi;Li Yongmei(Clinical Trial Center,The Fifth Affiliated Hospital of Guangzhou Medical University,Guangzhou 510700,China;Department of Pharmacy,Peking University People's Hospital,Beijing 100044,China)
出处
《国际医药卫生导报》
2023年第21期3127-3130,共4页
International Medicine and Health Guidance News
基金
广州市科技局广州市基础研究计划基础与应用基础研究项目(202102020201)
广州市卫生健康科技项目(20231A011110)。
关键词
临床试验
方案偏离
研究者管理
Clinical trials
Protocol deviation
Investigator management
