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.