Zhongguo Zhong Yao Za Zhi. 2026 Jul;51(13):3911-3916. doi: 10.19540/j.cnki.cjcmm.20260407.501.
ABSTRACT
Target trial emulation(TTE) has emerged in recent years as a key framework for causal inference, providing a methodological foundation for generating evidence with higher quality by using real-world data in situations where conducting a randomized controlled trial(RCT) is impossible. Transparent reporting of observational studies emulating a target trial: the TARGET statement published in 2025, proposed 21 core reporting items that systematically standardized the definition of the target trial, the emulation process, the identification assumptions, and the presentation of causal estimands, thereby providing a standardized foundation for the transparency, reproducibility, and criticizability of TTE research. For research on complex interventions in traditional medicine, the TARGET statement provided a directly applicable methodological framework for the transformation of complex TCM intervention research toward a standardized causal inference system, and it was conducive to establish a TCM evidence system anchored by target trials and supported by structured real-world data, thereby improving the efficacy evaluations for Chinese patent medicines and the evidence quality and interpretability of analyses of human use experience from renowned senior TCM experts. This paper comprehensively interpreted the TARGET statement, including its formulation context, scope of application, and key items, elucidated its methodological connotations, and focused on the mapping methods, statistical methods, and identification assumption requirements between target trial specifications and observational data. Building on this basis, this paper designated RCT of Chinese patent medicines or in-hospital preparations in clinical research as target trials and explored a TTE strategy for analyzing the human-use experience of TCM compound prescriptions by renowned senior TCM experts based on the prospective real-world disease-specific registration registries, thereby providing an operable research paradigm for its application in the field of clinical efficacy evaluation of TCM.
PMID:42543380 | DOI:10.19540/j.cnki.cjcmm.20260407.501
