摘要
自《药物临床试验质量管理规范》(GCP)实施以来,尤其是2015年以后,我国新药临床试验整体质量有了显著进步,但与发达国家相比较,还存在一些明显的质量问题。中药新药临床试验是我国新药临床试验的重要组成部分,除了一些共性问题以外,还存在跟中医药相关的特殊质量问题。在安全性数据方面如人用安全性数据收集不规范、申办者对非预期严重不良反应(SUSAR)处理与判断专业度不高及不及时、研究者对不良事件与试验药物关系判断依据不充分,有效性数据方面如量表类主要疗效指标无法溯源、中医证候数据达不到新修改GCP中对"源数据"的要求及中药安慰剂质量不高,在整体质量体系建设方面申办者、研究机构并未建立符合中药新药研究特点的质量保证体系等问题。中药新药临床试验质量在遵循我国现行GCP及ICH-GCP的大前提下,还应考虑中药新药临床试验本身的特点,针对这些特点制定有针对性的质量控制措施,以切实提高我国中药新药临床试验的整体质量,对促进我国中药新药研发具有重要的战略意义。
Since "the implementation of good clinical practice"(GCP), especially after 2015, the overall quality of new drug cli-nical trials in China has made significant progress, but compared with developed countries, there are still some obvious quality problems in clinical trials in China. Clinical trials of new drugs of traditional Chinese medicine are an important part of clinical trials of new drugs in China. In addition to some common problems in all clinical trials, there are also some special quality problems. In terms of security data, such as the collection of human safety data is not standardized, the management and judgment of unexpected serious adverse reactions(SUSAR) were not professional and timely, the relationship between adverse events and trial drug was not fully judged by investigator, In terms of effective data, such as primary efficacy outcome of the scale cannot be traced, TCM syndrome data cannot meet the requirements of "source data" in the revised GCP and the quality of traditional Chinese medicine placebo is not high, in terms of overall quality system construction, the sponsors and research institutions have not established a quality assurance system that conforms to the characteristics of new drug research of traditional Chinese medicine, etc. The quality of clinical trials of new drugs of traditional Chinese medicine is based on the current GCP and ICH-GCP in China, we should also consider the characteristics of clinical trials of new traditional Chinese medicine drugs, and formulate targeted quality control measures according to the characteristics of these new drugs of traditional Chinese medicine, to improve the overall quality of clinical trials of new drugs of traditional Chinese medicine in China, which has important strategic significance for promoting the research and development of new drugs of traditional Chinese medicine in China.
作者
元唯安
唐健元
高蕊
胡思源
赵艳玲
邹冲
李博
张俊华
张磊
杨忠奇
YUAN Wei-an;TANG Jian-yuan;GAO Rui;HU Si-yuan;ZHAO Yan-ling;ZOU Chong;LI Bo;ZHANG Jun-hua;ZHANG Lei;YANG Zhong-qi(Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Affiliated Hospital of Chengdu University of Traditional Chinese Medicine,Chengdu 610075,China;Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091,China;First Teaching Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300192,China;the First Affiliated Hospital of Hunan University of Traditional Chinese Medicine,Changsha 410000,China;Jiangsu Province Hospital of Chinese Medicine,Nanjing 210029,China;Beijing Hospital of Traditional Chinese Medicine,Capital Medical University,Beijing 100010,China;Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China;Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;the First Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510407,China)
出处
《中国中药杂志》
CAS
CSCD
北大核心
2021年第7期1701-1705,共5页
China Journal of Chinese Materia Medica
基金
国家“重大新药创制”科技重大专项(2017ZX09304002)
上海市促进市级医院临床技能与临床创新能力三年行动计划项目(20CR4003B)。
关键词
中药新药
临床试验
质量控制
专家共识
new drugs of traditional Chinese medicine
clinical trial
quality control
expert consensus
