Résumé
With reference to the comprehensive evaluation system for the clinical effectiveness of Chinese patent medicine， this paper summarized the current status and problems of the comprehensive evaluation of the clinical effectiveness of traditional Chinese medicine （TCM） in the treatment of malignant tumors from seven aspects， including safety， effectiveness， cost-effectiveness， innovation， suitability， accessibility， and TCM features. On this basis， the characteristics of TCM and the disciplinary characteristics of oncology are considered， and multiple sources of evidence， focus on dominant groups of people， consideration of economic toxicity， paying attention to post-marketing research， targeting at patients' willingness of medication， anchoring the supply of TCM services， and introducing symptoms threshold events are further emphasized. Moreover， methods such as nested case-control studies， enrichment designs， real-world research， and intelligent TCM diagnosis and treatment platforms are used to obtain high-level clinical evidence， ultimately building a scientific， homogeneous， and standardized comprehensive evaluation system for the clinical effectiveness of TCM in the treatment of malignant tumors.