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美国应用真实世界证据辅助医药产品监管决策的研究 |
Application to the Use of Real World Evidence Supporting Drug and Medical Device Regulatory Decisions in US |
投稿时间:2020-02-27 修订日期:2020-08-13 |
DOI: |
中文关键词: 真实世界证据 真实世界数据 医药产品 监管决策 |
英文关键词: realworld evidence realworld data medical products regulatory decisions |
基金项目: |
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中文摘要: |
目的:回顾美国FDA真实世界数据(RWD)与真实世界证据(RWE)的发展过程,总结出促进RWE应用所具有的关键要素,阐述RWE在医药产品监管决策中的机遇与挑战,为推动RWE在我国监管决策中的应用提出合理建议。方法:采用国内外文献研究,回顾美国FDA将RWE引入监管决策的相关立法及指南进程,分析在监管决策中引入RWE需考虑的关键问题。结果与结论:真实世界研究应当建立监管层面的通用数据标准,开发建设中国可以实际应用的患者登记系统、大型医疗数据共享系统等数据基础设施,遵循最佳方法标准进行研究设计。在医疗实践中结合以电子形式捕捉源数据、移动技术和远程医疗等先进技术,提高RWE在药品和器械审评、监管以及医保支付等决策中的应用。 |
英文摘要: |
Objective:Reviewing the development process of FDA Real World Data (RWD) and Real World Evidence (RWE), the key elements that promote the application of RWE are summarized, and the opportunities and challenges of RWE in drug and medical device regulatory decision-making are expounded in order to promote RWE's regulatory decision in China. some reasonable suggestions are put forward to promote the application of RWE in China's regulatory decision-making.Methods:By searching domestic and foreign literature and reviewing FDA's relevant legislation and guidelines for introducing RWE into regulatory decisions, analysis key issues to be considered in the introduction of RWE in regulatory decisions. Results and Conclusion:Real-world study should establish common data standards at the regulatory level, develop and build data infrastructures such as patient registration systems and large-scale medical data sharing systems that can be applied in China, and follow the best method standards for research design.Combining advanced technologies such as capturing source data in electronic form, mobile technology, and telemedicine in medical practice to improve the application of RWE in drug and device review, regulation, and medical insurance payment decision-making. |
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