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| 药物临床试验伦理审查常见问题及分析 |
| LIANG Xin1, XIAO Yan2△, ZHANG Ya-tong3, ZHANG Meng-qi1, XIA Rui,NING Xiao2,#,WANG Jia-qing4, # |
| 投稿时间：2023-09-01 修订日期：2023-12-04 |
| DOI： |
| 中文关键词: 伦理审查 志愿者 申办方 药物临床试验研究 |
| 英文关键词: Ethical review Volunteer Sponsor Clinical trial |
| 基金项目:国家重点研发计划(2021YFC2401103) |
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| 中文摘要: |
| 目的 通过研究不同分期药物临床试验研究中伦理初始审查意见,对药物临床试验伦理审查提交材料的准备提供建议。方法 回顾性统计分析北京某三级医院医学伦理委员会2017-2023年所有注册类药物临床试验伦理初始审查意见中常见的问题类型,比较它们在不同分期药物临床试验研究及新版《药物临床试验质量管理规范》实施前后的差异。结果 共计175份伦理初始审查,无一份初始审查通过。与伦理性相关的问题主要聚焦于“知情同意书告知的信息” 项中“预期的受益”和“志愿者的医疗与保护”项中的“提供志愿者的补偿”。而涉及科学性的问题主要为“研究方案的设计与实施”项中的“与试验目的有关的试验设计和对照组设置的合理性”。各类问题在不同分期药物临床试验研究中的发生率无差异。除“志愿者的医疗与保护”项中的“提供志愿者的补偿”外,其它两类问题在新版《药物临床试验质量管理规范》实施后呈现明显下降趋势。结论 提示相关从业人员在药物临床试验方案设计时要兼顾研究的科学性及伦理性,并且加强相关法律法规的学习,以规范项目的伦理申报,提高进展速度。 |
| 英文摘要: |
| Objective To provide suggestions for the preparation for ethical review of drug clinical trials by analysis the initial ethical review opinions in different stages of drug clinical trials. Methods A retrospective analysis of the ethical review opinions of the ethics committee of all drug clinical trials in a Tertiary general hospital in Beijing from 2017 to 2023 was carried out, and the common problems were compared in different stages of drug clinical trials and before and after the implementation of the new version of “Good clinical practice for drugs”. Results In total of 175 copies of ethical review opinions were received, none of which passed the initial review. The options were mainly focus on the "expected benefits" in the "information informed in the informed consent" and the "compensation for the subject" in the "medical treatment and protection of the subject". “The rationality of the experimental design and control group setting related to the experimental purpose” in the item of "Design and implementation of the research scheme" was mainly the scientific-related problems. There was no difference in the incidence of various problems in the clinical trial of drugs at different stages. In addition to "providing compensation for subjects" in the "medical treatment and protection of subjects", the other two types of problems showed a significant downward trend after the implementation of the new version of “Good clinical practice for drugs”. Conclusion It is suggested that the practitioners should consider both the scientific and ethical nature of the research when designing the drug clinical trial, and strengthen the study of relevant laws and regulations to standardize the ethical declaration of the project and improve the speed of progress. |
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