Discussion on Innovative Methods of the Clinical Efficacy Evaluation System for Traditional Chinese Medicine in the Context of Personalized Medicine
10.13288/j.11-2166/r.2024.23.001
- VernacularTitle:个体化诊疗视角下中医药临床疗效评价体系的优化方法探讨
- Author:
Xinrui QIU
1
;
Xiangjie LENG
2
;
Xinmei LAI
1
;
Zhaoyang YANG
1
;
Jiqian FANG
3
;
Candong LI
1
Author Information
1. Base for Research on Traditional Chinese Medicine Syndromes，Fujian University of Traditional Chinese Medicine，Fuzhou，350122
2. College of Ophthalmology，Chengdu University of Traditional Chinese Medicine
3. School of Public Health，Sun Yat-sen University
- Publication Type:Journal Article
- Keywords:
clinical efficacy evaluation;
personalized medicine;
traditional Chinese medicine;
ethical review;
clinical trials design;
data management;
statistical analysis
- From:
Journal of Traditional Chinese Medicine
2024;65(23):2389-2393
- CountryChina
- Language:Chinese
-
Abstract:
Personalized medicine emphasizes individualized and dynamic treatment decisions. There is an urgent need for a new efficacy evaluation system that can adapt to this approach. By reviewing past clinical research practices， this article pointed out the innovative needs of traditional Chinese medicine （TCM） efficacy evaluation from the perspective of personalized medicine in terms of ethical review， trial design， data management， and statistical analysis. Focusing on these needs， the article has proposed a strategic framework using syndrome differentiation and treatment in TCM as an example. The framework includes a method based on subgroup dynamic-static parallel group design and analysis， a safeguard mechanism of continuous review， dynamic informed consent， and multicenter ethical review， a technological support platform for personalized clinical efficacy evaluation and evidence support， and a statistical strategy integrating Bayesian and traditional analysis methods， aiming to promote the development of personalized TCM diagnosis and treatment.
