Application of objective performance criteria in post-marketing evaluation schemes of traditional Chinese medicine.
10.19540/j.cnki.cjcmm.20210203.501
- Author:
Chen ZHANG
1
;
Ming-Kun YU
2
;
Jin-Ping TANG
3
;
Yu-Qing HUO
3
;
Yu-Tong FEI
2
;
Zhi-Fei WANG
4
;
Qiang XU
1
;
Yan-Ming XIE
4
Author Information
1. Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine Tianjin 300150, China.
2. Centre for Evidence-based Chinese Medicine, Beijing University of Chinese Medicine Beijing 100029, China.
3. Tianjin University of Traditional Chinese Medicine Tianjin 301617, China.
4. Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China.
- Publication Type:Journal Article
- Keywords:
objective performance criteria;
post-marketing evaluation;
randomized controlled trial
- MeSH:
Drugs, Chinese Herbal;
Marketing;
Medicine, Chinese Traditional;
Nonprescription Drugs;
Product Surveillance, Postmarketing;
Randomized Controlled Trials as Topic
- From:
China Journal of Chinese Materia Medica
2021;46(8):1999-2003
- CountryChina
- Language:Chinese
-
Abstract:
Traditional Chinese medicines(TCMs) have certain limitations in the clinical research design in their post-marketing evaluation, so that randomized controlled programs cannot be strictly implemented in some studies, while the objective performance criteria is a reasonable external controlled research method that has been gradually recognized at home and abroad in recent years in addition to randomized controlled trial(RCT) method. It is more mature in medical devices, surgery and other research fields, but there is no relevant report in the field of post-marketing evaluation of Chinese patent medicines. In this paper, the application prospect of the objective performance criteria and the problems were discussed in the field of post-marketing evaluation of TCM. The characteristics of as TCM are more consistent with the scope of the objective performance criteria, the application of the objective performance criteria in post-marketing evaluation of Chinese patent medicines, especially in single arm research, can break through the limitations of existing conventional clinical research methods, and improve the level of evidence, with good feasibility and advantages. However, in the application process, we should pay attention to the key issues such as the selection of index, research population, follow-up period and the reference selection, to ensure the quality of research. This research group has carried out some exploration and practice in the field of post-marketing evaluation of TCM injections by using single arm combined with the objective performance criteria, hoping to establish the key technology in this field, and provide certain research and design reference for the secondary development of Chinese patent medicines.
