我国临床研究发展现状及中医临床研究存在的问题、策略和实践

临床研究是医学科学研究的重要组成部分，随着国家临床医学研究中心的建设，我国的临床研究 取得了较大的进展，但中医领域仍存在较多的问题，需加强研究目标、研究方法、过程监管、结果报告及证据转 化等环节的设计、优化和实施，切实提高中医临床研究的证据质量。团队通过建立中医群体、个体相结合的研 究评价方法、报告标准和质控技术，以及单病例随机对照试验和贝叶斯分析等个体化研究方法，整合了中医临 床研究的多来源证据体，并应用药症关联网络方法研究并阐释中医临床多途径微效应的特色机制，逐步形成全 面整体验证中医临床疗效的方法和技术体系，为中医临床研究的良性发展提供方法学支撑。

Developing Status of Clinical Research in China and the Existing Problems, Strategies and Practices of Clinical Research of Traditional Chinese Medicine

Clinical research is one of the most significant parts of medical scientific research. Clinical research in China has made great progress with the construction of the national center for clinical medical research. However, in the field of traditional Chinese medicine (TCM), it still exists many problems. The objectives, methods, supervision, reporting of the research and the translation of the research evidence have to be well designed, optimized and implemented so as to improve the evidence quality of clinical research of TCM. The clinical research evidence of TCM from multiple sources has been being integrated through the establishment of the evaluation methods for combining the group and individual research, the reporting standards and quality control techniques as well as the single case randomized controlled trials and Bayesian analysis. And the methodological and technological system has gradually formed for comprehensively assessing the curative effect of TCM together with the network methods associated with disease and medicine applied to explain characteristics and mechanism of the clinical efficacy of TCM. The system would provide a methodology support for the benign development of clinical research on TCM.