研究者发起的中医药临床研究伦理审查要点
Key points for ethical review of investigator-initiated clinical trials on traditional Chinese medicine
王晶1
作者信息
- 1. 首都医科大学附属北京中医医院伦理委员会办公室,北京 100010
- 折叠
摘要
中医药的发展源于大量的临床实践,通过临床研究验证中医药的疗效及其作用机制,验证中医药的独特价值,有利于中医药的传承和发展.目前,研究者发起的临床研究(IIT)数量越来越多,涉及中药干预的 IIT项目,在基础理论、辨证分型、组方配伍、剂型剂量等方面设计不同,更是对伦理委员会的项目审查提出了挑战.中医药与现代医学临床研究所遵循的基本伦理原则是一致的.中药干预的 IIT 项目的伦理审查,需要体现中医药自身发展规律,符合中药的特点及新药研发的规律.中医医疗机构需要结合专业特色,对临床经验方进行梳理,引导研究者以患者为中心,以临床价值为导向,有序开展中医药临床研究,验证中药新药的临床价值,提高中药新药成果转化的成功率.
Abstract
The academic development of traditional Chinese medicine(TCM)originates from numerous clinical practices.The efficacy of TCM,its mechanism of action,and the unique value of TCM have been verified through clinical research,contributing to TCM's inheritance and development.At present,there is an increasing number of investigator-initiated clinical trials(IIT).The IIT projects involving TCM intervention have different designs in terms of basic theory,syndrome differentiation,prescription composition,dosage form,dosage,and other aspects,as well as even posing challenges to the project review of the ethics committee.The basic ethical principles followed by clinical research institutions of modern medicine and TCM are consistent.The ethical review of the IIT projects involving TCM intervention needs to reflect the development laws of TCM itself,as well as conform to the characteristics of TCM and the laws of new drug research and development.TCM medical institutions need to combine their professional characteristics,sort out clinical experience,guide researchers to conduct clinical research on TCM in an orderly manner with a patient-centered and clinical value-oriented,verify the clinical value of TCM's new drugs,and improve the success rate of translating the results of TCM's new drugs.
关键词
中医药/研究者发起的临床研究/伦理审查Key words
traditional Chinese medicine/investigator-initiated clinical trial/ethical review引用本文复制引用
出版年
2025
国家科技期刊平台
NSTL
万方数据