| 薛桂琴.中、印、澳药物临床试验实施现状与监管对比研究[J].中国药事,2021,35(12):1327-1334 |
| 中、印、澳药物临床试验实施现状与监管对比研究 |
| Comparative Study on Implementation Status and Regulatory Characteristics of Drug Clinical Trials in China, India and Australia |
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| DOI：10.16153/j.1002-7777.2021.12.001 |
| 中文关键词: 药物临床试验 临床试验实施现状 临床试验监管 国内外对比 完善监管措施 |
| 英文关键词: drug clinical trials clinical trial implementation status clinical trial supervision comparison at home and abroad improve regulatory measures |
| 基金项目: |
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| 摘要点击次数: 1057 |
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| 中文摘要: |
| 目的： 选取药物临床试验市场广阔的印度及药物临床试验监管历史悠久的澳大利亚，就临床试验实施现状与监管方式两方面与我国进行对比，为我国临床试验的科学监管提供对策。方法：采取文献研究法、比较分析法等理论分析方法，从国内外的法律法规、试验流程、试验对象等角度分析探讨，对比国内外临床试验监管的异同。结果：临床试验是对药物的有效性、安全性进行科学评估的过程，是药物研发过程中的重要环节。随着我国医药行业的蓬勃发展，药物临床试验数量大幅增加，但临床试验管理中暴露的诸多问题也不容小觑。我国临床试验监管尚存在不足，临床试验优势资源紧缺，临床试验管理体系仍不完善。结论：我国应当有效借鉴国外经验、汲取教训，制定更为完善的监管措施与规范制度， 保障药物临床试验的质量，优化我国药物临床试验的监管水平。 |
| 英文摘要: |
| Objective: India with a broad drug clinical trial market, and Australia with a long history of drug clinical trial supervision, were chosen to compare the implementation status and supervision methods of clinical trials with China, so as to provide countermeasures for the scientific supervision of clinical trials in China. Methods: Theoretical analysis methods such as literature research, comparative analysis were adopted.To analyze and discuss from the perspectives of domestic and foreign laws and regulations, test processes, test objects, and the differences in clinical trial supervision between domestic and foreign countries were compared. Results: Clinical trial is a process of scientific evaluation of the effectiveness and safety of drugs, and it is an important link in the process of drug development. With the vigorous development of pharmaceutical industry in China, the number of clinical trials of drugs has increased significantly, but more and more problems in the management of clinical trials should not be underestimated. Clinical trial supervision in our country is still inadequate, superior clinical trial resources are scarce, and the clinical trial management system is still incomplete. Conclusion: China should learn from foreign experience, formulate more perfect supervision and regulations, and improve the quality of drug clinical trials, to truly improve the level of supervision of drug clinical trials in China. |
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