Challenges and Recommendations for Implementing Key Technologies in Decentralized Clinical Trials of Traditional Chinese Medicine
10.13288/j.11-2166/r.2026.09.002
- VernacularTitle:中医药去中心化临床试验关键技术实施的挑战与建议
- Author:
Runze WANG
1
;
Xuehan WEI
1
;
Xiaoying CHEN
2
;
Yingqian ZHANG
1
;
Jin SUN
3
;
Chunli LU
1
Author Information
1. Institute of Traditional Chinese Medicine，Guangdong Pharmaceutical University （Guangdong Metabolic Diseases Research Center of Integrated Chinese and Western Medicine），Guangzhou，510006
2. Graduate School，Beijing University of Chinese Medicine
3. First Clinical Medical College，Nanjing University of Chinese Medicine
- Publication Type:Journal Article
- Keywords:
traditional Chinese medicine clinical trials;
decentralized clinical trials;
remote intelligent clinical trials;
digital health technology;
digitalization of traditional Chinese medicine
- From:
Journal of Traditional Chinese Medicine
2026;67(9):926-934
- CountryChina
- Language:Chinese
-
Abstract:
Traditional Chinese medicine （TCM） clinical trials face challenges such as low participant compliance， insufficient geographical coverage， and cost-effectiveness imbalances. Decentralized clinical trials （DCT）， enabled by digital technology for remote data collection and monitoring， offer a new direction for TCM clinical trial research. This article systematically reviews three novel clinical trial design models. Combining the holistic concept and indivi-dualized treatment characteristics of TCM， it analyzes the challenges currently faced in TCM DCT practice， including the digitization and standardization of TCM theory， data security， privacy protection and patient engagement difficu-lties， insufficient ethical review and regulatory system adaptation， inadequate personnel training， and a shortage of interdisciplinary talent. Addressing these challenges， the article proposes methodological recommendations for DCT implementation that align with the principles of TCM diagnosis and treatment. These recommendations include promoting the intelligentization and standardization of TCM practices， constructing a full-chain data security and privacy protection system， improving the ethical framework and clarifying regulatory responsibilities， and cultivating and building interdisciplinary talent and capabilities， which provide theoretical and technical references for establishing standardized DCT practices in TCM.
