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| 临床试验过程中不依从/ 违背或偏离方案的分析与探讨 |
| Analysis and discussion of non-compliance / violation or deviation from scheme in clinical trials |
| 投稿时间：2020-03-28 修订日期：2020-04-12 |
| DOI： |
| 中文关键词: 临床试验 不依从/ 违背或偏离方案 分析与探讨 |
| 英文关键词: clinical trial, non-compliance/violation or deviation from scheme, Analysis and discuss |
| 基金项目:北京大学科研管理科题 |
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| 摘要点击次数: 212 |
| 中文摘要: |
| [摘要] 目的 收集分析2017年至2019年笔者所在伦理委员会接收审查的不依从/ 违背或偏离方案报告，研究探讨事件发生的规律、挖掘问题层面的原因和逻辑，为临床研究不依从/ 违背或偏离方案相关的研究探索、管理改革和执行改善提供数据基础、经验总结和初步建议。方法 利用SPSS v21软件，采用卡方检验、非参数检验等方法对收集的754份报告进行分析比较和总结归纳，讨论并给出初步建议。结果 三年累计接收不依从/ 违背或偏离方案的报告754份共计4878例次事件，数据涉及28个科室219个项目，项目来源包括药物/医疗器械临床试验占88%，研究者发起科研项目占12%。事件类型总结整理为七个方面，
在项目来源、试验类型与临床试验专业等方面分布差异有统计学意义。同时，研究者提交报告的规范性总体差。结论 不依从/ 违背或偏离方案事件类型及发生数量与试验类型及临床试验专业比较均有统计学差异，但临床研究者在研究过程中对伦理委员会批准方案的遵从程度，特别是不依从/ 违背或偏离方案事件发生后，报告的规范性、判断的逻辑性、整改措施的有效性都有较大的提升余地，也是下一步临床研究者与伦理管理者共同研究解决的方向。 |
| 英文摘要: |
| Abstract Objective To collect and analyze the non-compliance/violation or deviation events received by the Ethics Committee of the author’s hospital from 2017 to 2019, to explore regular pattern of relevant reports and to mine the deep cause and logic of the problem. The data basis, lessons and preliminary advice were provided to improve the research, managerial revolution and execution about non-compliance/violation or deviation events in clinical trials. Methods The chi-square test and non-parameter test were conducted using SPSS 21.0. 754 reports received were analyzed, compared, discussed and concluded to form preliminary advice. Results From 2017 to 2019,754 reports on ono-comliance/violation or deviation from scheme which are involved in 219 programs in 29 clinical sections were received.The project resource included drug/medical apparatus clinical trials(88%),scientific research project initiated by researchers(12%).Events types are summaried into 7 aspects.The distribution on various project resources,trial types and clinical specialties are significantly different.Meanwhile,it is bad in standardization of reports submitted by researchers.Conclusions The types and number of non-compliance/violation or deviation from sheme events are significantly related to trial types and clinical trial specialities.However,the degree of compliance of clinical researchers with the scheme approved by the Ethics Committee during the research process is low. Especially when the event of non-compliance/violation or deviation from the plan occurred, there is spacious room for investors to promote standardization of report, logic of judgment and effectiveness of rectification measures. This is also the direction of solving the problem for clinical researchers and ethical managers. |
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