基于真实世界数据的中成药安全性评价模式构建

目的 构建基于真实世界数据的中成药安全性评价模式,为研究者和决策者正确生产和使用基于真实世界数据的中成药安全性评价证据提供参考.方法 通过查阅国内外文献总结真实世界数据在中成药安全性评价中的作用,探索构建基于真实世界数据的中成药安全性评价模式.结果 从药品监管的角度,提出了基于常规收集和主动收集的真实世界数据开展中成药...

Developing a safety assessment model for Chinese patent medicines based on real-world data

Objective To develop a safety assessment model for Chinese patent medicines based on real-word data,so as to provide reference for researchers and decision makers to scientifically and rationally produce and use real-world-data-based safety assessment evidence of Chinese patent medicines.Methods We summarized the role of real-world data in the safety assessment of Chinese patent medicines by referring to domestic and foreign literatures,explored and developed the safety assessment model of Chinese patent medicines based on real-world data.Results We proposed,from the perspective of drug regulation,a safety assessment research model for Chinese patent medicines based on routinely collected and actively collected real-world data,and its application was illustrated with an example.Conclusion Real-world data plays an important role in the safety assessment of Chinese patent medicines,but there are still some limitations.There is an urgent need to introduce new study design and statistical analysis methods in this field.