Guideline for clinical comprehensive evaluation of Chinese patent medicine (2022 version).
- Author:
Wei-An YUAN
1
;
Jun-Hua ZHANG
2
;
Jian-Ping LIU
3
;
Zhong-Qi YANG
4
;
Jun-Ling CAO
5
;
Xing LIAO
6
;
Xiao-Yu XI
7
;
Mei HAN
3
;
Wen-Yuan LI
8
;
Zhen-Wen QIU
4
;
Shi-Yin FENG
4
;
Yuan-Yuan GUO
9
;
Lu-Jia CAO
2
;
Xiao-Hong LIAO
4
;
Yan-Ling AI
8
;
Ju HUANG
8
;
Lu-Lu JIA
10
;
Xiang-Fei SU
11
;
Xue WU
6
;
Ze-Qi DAI
6
;
Ji-Hua GUO
11
;
Bing-Qing LU
8
;
Xiao-Xiao ZHANG
11
;
Jian-Yuan TANG
8
Author Information
- Publication Type:Journal Article
- Keywords: Chinese patent medicine; clinical comprehensive evaluation; guideline; health technology assessment
- MeSH: Medicine, Chinese Traditional; Nonprescription Drugs; Consensus; China; Reference Standards; Drugs, Chinese Herbal
- From: China Journal of Chinese Materia Medica 2023;48(1):256-264
- CountryChina
- Language:Chinese
- Abstract: Currently,the research or publications related to the clinical comprehensive evaluation of Chinese patent medicine are increasing,which attracts the broad attention of all circles. According to the completed clinical evaluation report on Chinese patent medicine,there are still practical problems and technical difficulties such as unclear responsibility of the evaluation organization,unclear evaluation subject,miscellaneous evaluation objects,and incomplete and nonstandard evaluation process. In terms of evaluation standards and specifications,there are different types of specifications or guidelines with different emphases issued by different academic groups or relevant institutions. The professional guideline is required to guide the standardized and efficient clinical comprehensive evaluation of Chinese patent medicine and further improve the authority and quality of evaluation. In combination with the characteristics of Chinese patent medicine and the latest research achievement at home and abroad,the detailed specifications were formulated from six aspects including design,theme selection,content and index,outcome,application and appraisal,and quality control. The guideline was developed based on the guideline development requirements of China Assoication of Chinese medicine. After several rounds of expert consensus and public consultation,the current version of the guideline has been developed.
