中国临床研究的数字化转型:前沿探索与未来展望

Digital Transformation of Clinical Research in China:Frontier Exploration and Future Prospects

我国临床研究正在经历数字化转型,以提高质量和影响力,其面临着诸多挑战,包括真实世界数据与临床研究之间的差距,伦理问题和数据安全性等。本文总结了我国研究人员在乐城先行区进行的试点工作和实践成果,包括真实世界数据采集和管理工具、特许创新药械的研究模式、真实世界数据在医疗决策和监管中的应用、研究设计和统计分析、规范与技术、中成药研究、伦理问题与数据安全性以及药械审批与监管。未来,我国临床研究有望在人工智能、大数据、远程监测、跨学科研究等领域实现更多的创新,与此同时更需要关注伦理和隐私问题,确保数字化转型的安全和可持续性,以期为全球医疗领域的进步做出贡献。

Clinical research in China is undergoing a digital transformation to enhance its quality and impact.Challenges include bridging the gap between real-world data and clinical research,ethical concerns,and data security.This paper summarizes the pilot work and practical achievements of domestic researchers in the Lecheng Pilot Zone,including real-world data collection and management tools,innovative research models for proprietary medical devices,the application of real-world data in medical decision-making and regulation,research design and statistical analysis,standards and technology,traditional Chinese medicine research,ethical concerns and data security,as well as medical device approval and regulation.In the future,clinical research in China is expected to achieve more innovations in areas such as artificial intelligence,big data,remote monitoring,interdisciplinary research,while also paying attention to ethical and privacy issues to ensure the safety and sustainability of digital transformation and contribute to the advancement of the global healthcare sector.