Expert consensus on key issues of quality control in clinical trials of new drugs of traditional Chinese medicine.
10.19540/j.cnki.cjcmm.20210219.501
- Author:
Wei-An YUAN
1
;
Jian-Yuan TANG
2
;
Rui GAO
3
;
Si-Yuan HU
4
;
Yan-Ling ZHAO
5
;
Chong ZOU
6
;
Bo LI
7
;
Jun-Hua ZHANG
8
;
Lei ZHANG
9
;
Zhong-Qi YANG
10
Author Information
1. Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine Shanghai 201203, China.
2. Affiliated Hospital of Chengdu University of Traditional Chinese Medicine Chengdu 610075, China.
3. Xiyuan Hospital, China Academy of Chinese Medical Sciences Beijing 100091, China.
4. First Teaching Hospital of Tianjin University of Traditional Chinese Medicine Tianjin 300192, China.
5. the First Affiliated Hospital of Hunan University of Traditional Chinese Medicine Changsha 410000, China.
6. Jiangsu Province Hospital of Chinese Medicine Nanjing 210029, China.
7. Beijing Hospital of Traditional Chinese Medicine, Capital Medical University Beijing 100010, China.
8. Tianjin University of Traditional Chinese Medicine Tianjin 301617, China.
9. Shanghai University of Traditional Chinese Medicine Shanghai 201203, China.
10. the First Affiliated Hospital of Guangzhou University of Chinese Medicine Guangzhou 510407, China.
- Publication Type:Journal Article
- Keywords:
clinical trial;
expert consensus;
new drugs of traditional Chinese medicine;
quality control
- MeSH:
China;
Clinical Trials as Topic;
Consensus;
Drugs, Chinese Herbal/therapeutic use*;
Humans;
Medicine, Chinese Traditional;
Quality Control
- From:
China Journal of Chinese Materia Medica
2021;46(7):1701-1705
- CountryChina
- Language:Chinese
-
Abstract:
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.
