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 per-spective 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.
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