Current Status and Optimization Strategies for Setting Objective Performance Criteria in Clinical Trials of Traditional Chinese Medicine
10.13288/j.11-2166/r.2026.13.018
- VernacularTitle:中医药临床试验目标值制定的现状与优化策略
- Author:
Jiaqi LAI
1
;
Qian HUANG
1
;
Xueyin CHEN
1
;
Shaonan LIU
1
;
Lihong YANG
1
;
MIMAZHUOGA
2
;
DAWA
2
;
Zhijian LI
3
;
Tuerxun WUFUER
3
;
Xinfeng GUO
1
Author Information
1. Guangdong Provincial Hospital of Chinese Medicine/The Second Affiliated Hospital of Guangzhou University of Chinese Medicine，Guangzhou，510120
2. Hospital of Traditional Tibetan Medicine Tibetan Medical & Astro Institute
3. Uygur Medicine Hospital of Xinjiang Uygur Autonomous Region/The Second People's Hospital of Xinjiang Uygur Autonomous Region
- Publication Type:Journal Article
- Keywords:
traditional Chinese medicine clinical trial;
ethnic minority medicine;
objective performance criteria method;
clinical research method
- From:
Journal of Traditional Chinese Medicine
2026;67(13):1461-1464
- CountryChina
- Language:Chinese
-
Abstract:
Current formulation of objective performance criteria （OPC） in traditional Chinese medicine （TCM） faces methodological challenges， including poor reporting quality， insufficient standardization of methods， limited comparability of study populations， and inadequate consideration of the genetic and environment particularities of ethnic minority populations. In response to these issues， this paper proposes optimization strategies for setting OPC in TCM， with particular attention to ethnic minority medicine. These include improving methodological techniques and statistical descriptions， ensuring transparency in meta-analyses and data sources； standardizing the estimation of point estimates and confidence intervals， and incorporating multidisciplinary expert consensus for value determination； introducing local real-world data from the same period， especially cohort study evidence， to compensate for the lack of high-quality randomized controlled trial data. Through process transparency and dynamic updating mechanisms， the credibility of OPC method can be enhanced， thereby providing methodological support for strengthening evidence-based research capacity in this field.
