Application of objective performance criteria in post-marketing evaluation schemes of traditional Chinese medicine / 中国中药杂志
China Journal of Chinese Materia Medica
; (24): 1999-2003, 2021.
Article
em Zh
| WPRIM
| ID: wpr-879121
Biblioteca responsável:
WPRO
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.
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WPRIM
Assunto principal:
Vigilância de Produtos Comercializados
/
Medicamentos de Ervas Chinesas
/
Ensaios Clínicos Controlados Aleatórios como Assunto
/
Marketing
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Medicamentos sem Prescrição
/
Medicina Tradicional Chinesa
Tipo de estudo:
Clinical_trials
/
Diagnostic_studies
Idioma:
Zh
Revista:
China Journal of Chinese Materia Medica
Ano de publicação:
2021
Tipo de documento:
Article