Report standards for clinical comprehensive evaluation of Chinese patent medicine.
10.19540/j.cnki.cjcmm.20210930.502
- Author:
Qiang ZHANG
1
;
Zhi-Fei WANG
1
;
Yan-Ming XIE
1
;
Yuan-Yuan LI
1
;
Lian-Xin WANG
1
;
Huan LIU
1
;
Hong-Jiao GENG
1
;
Xin CUI
1
;
Fu-Mei LIU
1
;
Chun-Quan SUN
1
;
Rui-Li WEI
1
;
Li-Dan ZHANG
1
Author Information
1. Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China.
- Publication Type:Journal Article
- Keywords:
Chinese patent medicine;
clinical comprehensive evaluation;
clinical evidence;
report standard;
value
- MeSH:
China;
Drugs, Chinese Herbal;
Information Storage and Retrieval;
Medicine, Chinese Traditional;
Nonprescription Drugs;
Quality Control
- From:
China Journal of Chinese Materia Medica
2021;46(23):6062-6067
- CountryChina
- Language:Chinese
-
Abstract:
The clinical comprehensive evaluation of drugs is an important basis for the return of clinical value, decision-making of medical and health authorities, and allocation of medical resources. In July 2021, the National Health Commission issued the Guidelines for the Management of Clinical Comprehensive Evaluation of Drugs(trial version 2021), which required the evaluation to be implemented from the six dimensions(safety, effectiveness, economy, innovation, suitability, and accessibility), and made detailed arrangements for the clinical comprehensive evaluation of drugs. As Chinese patent medicine differs from chemical medicines in terms of effective components and action modes, the clinical comprehensive evaluation of Chinese patent medicine should highlight the characteristics and advantages of traditional Chinese medicine(TCM) on the basis of general requirements of comprehensive clinical evaluation of drugs. At present, in the clinical comprehensive evaluation of Chinese patent medicine, unified report standards have not yet been generated, resulting in the uneven quality of existing reports. To standardize the clinical comprehensive evaluation report of Chinese patent medicine and improve its quality, the editorial team, based on the relevant policy documents of clinical comprehensive evaluation of drugs, formulated the clinical comprehensive evaluation report standards for Chinese patent medicine in combination with the previous practice and expert opinions. The report standards, containing seven sections with 15 items determined, focus on data source, evaluation content, evidence synthesis, quality control, and evaluation results supported with detailed interpretations to help researchers better understand and apply the report standards for clinical comprehensive evaluation of Chinese patent medicine, improve the report quality, and provide references for the decision-making by the national medical management authorities.
