中医眼科优势病种临床研究的监管科学实践与思考

Practice and thinking of regulatory science in clinical research for the dominant diseases of Chinese ophthalmology

中医眼科学是中医学的重要分支,中医眼科优势病种相关中药新药的研发越来越受到关注。开展中医眼科优势病种临床研究有利于发挥中医药理论和中医临床实践的价值,挖掘患者获益和中药治疗的优势和特点,提升眼健康。借助中药监管科学研究,进一步发展具有符合中药特点的新工具、新标准和新方法,可以减少监管决策时的不确定性,满足人民用药的可及性。文章结合审评工作,着重介绍中医眼科优势病种临床研究中需关注的问题,以服务临床研究与评价,加速眼科中药新药的转化应用,促进中药传承创新和高质量发展。

Traditional Chinese ophthalmology is an important branch of traditional Chinese medicine(TCM),the development of TCM new drugs related to the dominant diseases of Chinese ophthalmology has attracted more and more attention.Conducting clinical research in the dominant diseases of Chinese ophthalmology is benefit for leveraging the value of TCM theory and clinical practice,exploring the advantages and characteristics of patient benefits and traditional Chinese medicine treatment,and improving eye health.In regulatory science,the development of new tools,new standards and new methods with the characteristics of TCM will reduce the uncertainty in regulatory decision-making and meet the accessibility of medicine.Combined with the drug review,this paper focuses on the effectiveness evaluation of TCM supervision and control of dominant diseases in Chinese ophthalmology.It can serve clinical research and evaluation,accelerate the transformation and application of TCM new drugs in ophthalmology,and promote the inheritance,innovation and high-quality development of TCM.