规范研究者依从性对提高药物临床试验质量的探索与实践  

Exploration and Practice of Standardizing Researchers’Compliance to Improve the Quality of Drug Clinical Trials

作　　者：谭婷[1] 李静[1] 姚澜 李涵[1] 赵阳[1] 李宗芳[1] Tan Ting;Li Jing;Yao Lan;Li Zongfang(The Second Affiliated Hospital of Xi’an Jiaotong University,Xi’an,Shaanxi,710004,China;不详)

机构地区：[1]西安交通大学第二附属医院,陕西西安710004

出　　处：《中国医院管理》2022年第7期62-64,共3页Chinese Hospital Management

基　　金：陕西省创新能力支撑计划——软科学研究计划面上项目(2017KRM183)。

摘　　要：目的旨在规范研究者依从性,保证药物临床试验质量。方法针对影响研究者依从性的常见问题,制定相应措施,并对优化前后效果进行对比分析。结果医院项目质控中发现试验记录、安全性事件、试验药物等与研究者依从性相关的问题占比达60%以上,采取措施后,改善幅度明显,且整体上平均每例存在问题数量和每项存在问题数量均显著降低。结论提高研究者依从性,对保证药物临床试验质量及提升临床研究水平意义重大。Objective To further standardize the researchers’compliance,ensuring the quality of drug clinical trials.Methods Based on the problems affecting the researchers’compliance,corresponding measures were formulated,and the effects before and after optimization were compared and analyzed.Results The project quality control in the hospital found that more than 60%of the problems related to the researcher compliance,including trial records,safety events and experimental drugs.After implementing the measures,the improvement was obvious.The average number of problems per case and the number of problems per item were significantly reduced.Conclusion Improving researcher compliance is of great significance to ensure the quality of clinical trials and improve the level of clinical research.

关 键 词：研究者 依从性 药物临床试验 质量管理 

分 类 号：R197.323.6[医药卫生—卫生事业管理]