Overall strategy for development and application of core outcome set of traditional Chinese medicine.
10.19540/j.cnki.cjcmm.20250604.502
- Author:
Jun-Hua ZHANG
1
;
Bo PANG
1
;
Yu-Yun LI
1
;
Hui-Zhong ZHU
1
;
Feng-Wen YANG
1
;
Bo-Li ZHANG
1
Author Information
1. Tianjin University of Traditional Chinese Medicine Tianjin 301617, China Key Laboratory of Evidence Based Evaluation of Traditional Chinese Medicine, National Medical Products Administration Tianjin 301617, China.
- Publication Type:English Abstract
- Keywords:
core outcome set;
development strategy;
traditional Chinese medicine
- MeSH:
Medicine, Chinese Traditional/methods*;
Humans;
Drugs, Chinese Herbal/standards*
- From:
China Journal of Chinese Materia Medica
2025;50(13):3506-3512
- CountryChina
- Language:Chinese
-
Abstract:
The scientific and standardized evaluation of clinical efficacy of traditional Chinese medicine(TCM) is the core requirement for promoting the high-quality development of TCM. Building a recognized evaluation outcome system that conforms to the clinical efficacy characteristics of TCM is a key fundamental issue in the production and transformation of clinical evidence in TCM. In response to the heterogeneity of evaluation outcomes and core issues such as "western law in the middle", the research on the core outcome set of TCM(COS-TCM) has undergone more than ten years of exploration and practice. Its methodological system has continued to deepen under the coordinated development of theoretical basis, technical methods, platform support, and talent team, achieving an important leap from early introduction to standardized system construction and entering a new stage of systematic development. However, the overall research scale, quality, and the translation and application of research results in COS-TCM are still insufficient. In response to the opportunities and challenges of the new development stage, this article systematically reviews the development history and research status of COS-TCM, clarifies the basic principles of "international standards + TCM characteristics" and the key tasks of "selection, improvement, and creation", and proposes a three-step development path of "exploration and research, standard development, and regulatory transformation" to promote the standardization, systematization, and scientific development of related research. To ensure the effective implementation of research results, key promotion strategies such as upgrading research platforms, strengthening support systems, and optimizing collaborative mechanisms have been planned to drive COS-TCM to better serve clinical research, evidence translation, and new drug review.
