| 梁欣,肖妍,张亚同,张梦琦,夏瑞,宁霄,王佳庆.药物临床试验伦理审查常见问题及分析[J].中国药事,2023,(12):1369-1374 |
| 药物临床试验伦理审查常见问题及分析 |
| Common Issues and Analysis on the Ethical Review for Drug Clinical Trials |
| 投稿时间：2023-09-01 |
| DOI：doi:10.16153/j.1002-7777.2023.12.004 |
| 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 drug clinical trial |
| 基金项目:国家重点研发计划（编号 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，为药物临床试验伦理审查提交材料的准备提供建议。方法：回顾性统计分析首都医科大学附属北京潞河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”。涉及科学性的问题主要为“研究方案的设计与实施”项中“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 on the preparation of submission materials for ethical review ofdrug clinical trials by investigating the initial ethical review opinions in diff erent stages of drug clinical trials.Methods: The common types of problems in the initial ethical review opinions of all registered drug clinicaltrials in the Medical Ethics Committee of Beijing Luhe Hospital Affi liated to Capital Medical University from2017 to 2023 were retrospectively analyzed, and the differences in different stages of drug clinical trials andbefore and after the implementation of the new version of "Good Quality Management for Drug Clinical Trials" were compared. Results: A total of 175 copies of ethical reviews were conducted, none of which passed. Theissues related to ethics mainly focused on the "expected benefi ts" in the item "information informed by informedconsent" and the "compensation provided to volunteers" in the item "medical care and protection of volunteers"."The rationality of the experimental design and control group setting related to the experimental purpose" in theitem of "design and implementation of the research scheme" was mainly the scientifi c-related issues. There wasno diff erence in the incidence of various problems in the clinical trial of drugs at diff erent stages. In addition to"compensation provided to volunteers" in the item of "medical care and protection of volunteers", the other twotypes of problems showed a signifi cant downward trend after the implementation of the new version of the "GoodManagement for Drug Clinical Trials". Conclusion: It is suggested that the relevant practitioners should considerboth the scientifi c and ethical nature of the research when designing the drug clinical trial scheme, and strengthenthe study of relevant laws and regulations to standardize the ethical declaration of the project and improve thespeed of progress. |
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