| 阮姝楠,吴旭东.医院生物等效性试验过程中方案偏离的分析与改进[J].安徽医药,2019,23(11):2316-2319. |
| 医院生物等效性试验过程中方案偏离的分析与改进 |
| Analysis and improvement on the protocol deviation during the bioequivalence test in the hospital |
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| DOI：10.3969/j.issn.1009?6469.2019.11.053 |
| 中文关键词: 临床试验(主题) 规范 质量控制 生物等效性试验 方案偏离 类别 原因 解决对策 |
| 英文关键词: Clinical trials as topic Benchmarking Quality control Bioequivalence test Protocol deviation Category Cause Solution |
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| 中文摘要: |
| 目的减少方案偏离的发生，提高生物等效性试验的质量。方法分析 2018年5月至 2019年 5月武汉市金银潭医院开展的生物等效性试验项目，对其中的方案偏离进行回顾性研究并归类分析，探讨方案偏离的类别、例数，并提出改进措施。结果 2018年 5月至 2019年 5月开展生物等效性试验 31项， 23个项目发生方案偏离，发生 532例次。按项目统计，发生的方案偏离最多的为血样采集方面偏离( 51.61%)、未按方案进行实验室检查( 38.71%)和饮食管理的方案偏离( 19.35%)；按发生例次统计，发生方案偏离最多的是未按方案进行实验室检查( 58.53%)、签署知情同意不规范( 15.60%)和血样采集( 9.21%)。结论建议设计符合临床实际的试验方案，加强针对项目关键点的培训及项目中的沟通，建立完善的质量保证体系，减少方案偏离的发生。 |
| 英文摘要: |
| Objective Analyze the types of protocol deviations in the bioequivalence test，so as to provide reference for reducing the occurrence of program deviation and improving the quality of bioequivalence test.Methods The bioequivalence test project carried out by Wuhan Infectious Disease Hospital from 2018 to May 1919 was analyzed，and the deviation of the program was retro? spectively studied and classified，and the types and cases of the program deviation were discussed and improvement suggession were provideds.Results In our hospital from May 20 to 2019，31 bioequivalence tests were carried out，and 23 projects occurred in 532 cases.According to the statistics of the project，the deviation of the program occurred was the deviation of the blood sample collection(51.61%)， the laboratory inspection(38.71%) and the catering program deviation(19.35%).According to the occur? rence statistics，the occurrence most deviations were protocol deviationsof laboratory tests(58.53%)， irregular informed consent(15.60%)andbloodsamplecollection(9.21%).Conclusion It is recommended to design a trial plan that conforms to the clinical practice，strengthen communication in the training and project in the project，establish a sound quality assurance system，and re? duce the occurrence of program deviation. |
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