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.
Zhongguo Zhong Yao Za Zhi. 2021 Apr;46(7):1701-1705. doi: 10.19540/j.cnki.cjcmm.20210219.501.
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.
自“药物临床试验质量管理规范”（GCP）实施以来，特别是2015年之后，中国新药临床试验的整体质量取得了显著进步，但与发达国家相比，中国的临床试验仍存在一些明显的质量问题。中药新药临床试验是中国新药临床试验的重要组成部分。除了所有临床试验中存在的一些常见问题外，还存在一些特殊的质量问题。在安全性数据方面，如人体安全性数据的收集不规范、严重不良事件（SUSAR）的管理和判断不专业不及时、研究者对不良事件与试验药物之间的关系判断不充分；在有效性数据方面，如量表的主要疗效指标无法溯源、中医证候数据不符合修订后GCP中“源数据”的要求、中药安慰剂质量不高；在整体质量体系建设方面，申办者和研究机构未建立符合中药新药研究特点的质量保证体系等。中药新药临床试验质量基于中国现行的GCP和ICH - GCP，还应考虑中药新药临床试验的特点，根据这些中药新药的特点制定有针对性的质量控制措施，以提高中国中药新药临床试验的整体质量，这对推动中国中药新药研发具有重要的战略意义。
