中医药临床研究的未来发展趋势及思考

Future Development Trends and Considerations for Clinical Research of Traditional Chinese Medicine

摘要:

数字化时代的到来促进了临床研究从传统模式向数字化模式发展，数字化技术引入中医药临床研究可优化研究设计、提高研究质量、节约研究经费及时间。计算机、网络及传感器等技术手段使得临床研究招募及筛选、疾病诊断及治疗、知情同意、指标测量等流程的数字化及远程操控得以真正实现。人工智能（AI）算法、可穿戴监测设备、数据管理工具、区块链及虚拟临床试验（VCT）是临床研究的关键创新技术及研究设计方法。基于此，该研究对AI算法、可穿戴监测设备、数据管理工具、区块链及VCT等数字化关键技术及研究方法进行相关文献总结分析后发现，中医药临床研究的未来发展需要重视数字化技术带来的临床研究技术革新，并进一步深化数字化技术在中医药临床研究中的应用。数字化技术实现了“以人为本”的医学伦理观念，促进了临床研究的去中心化，简化了研究受试者的参与流程，降低了临床研究时间及成本，提高了中医药临床研究的效率，增强了中医药临床研究的客观性、真实性及稳定性。深化数字化技术的临床研究应用、实现多种数字化技术交叉融合使用是中医药临床研究未来发展的必然趋势。在数字化时代背景下，中医药临床研究的数字化革新可推动中医药临床研究发展，促进中医药的国际化进程。

Abstract:

The advent of digital times promotes the evolution of clinical research from traditional mode to digital mode. Digital technologies， which are introduced to clinical research of traditional Chinese medicine （TCM）， can optimize the research design， improve research quality， and save research funds and time. The digital and remote control of clinical research recruitment and screening， disease diagnosis and treatment， informed consent， indicator measurement， and other processes can be realized by computers， networks， sensors， and other technologies. Artificial intelligence （AI） algorithms， wearable monitoring devices， data management tools， blockchain， and virtual clinical trials （VCTs） are key innovation technologies and research design methods. On this basis， this study summarized relevant literature on key digital technologies and research methods such as AI algorithms， wearable monitoring devices， data management tools， blockchain， and VCT， and the following discoveries were obtained： The future development of clinical research of TCM requires to attach importance to the changes in clinical research brought by digital technologies and to promote the utilization of digital technologies in clinical research of TCM. Digital technologies realize the medical ethical ideas of ''putting people first''， promote the decentralization of clinical research， simplify the participation process of participants， reduce the time and cost of clinical research， improve the efficiency of clinical research of TCM， and enhance the objectivity， authenticity， and stability of clinical research of TCM. Deepening the application of digital technologies in clinical research and realizing the interaction and fusion of various digital technologies are inevitable trends of future development of clinical research of TCM. Under the background of digitization， the digital innovation of clinical research of TCM can accelerate the development of clinical research of TCM and promote the internationalization of TCM.