The invention belongs to the field of RCT (randomized controlled trial), and relates to a real-data-based simulative RCT analysis method. The analysis method is a data analysis method for comparative effectiveness researches, is used for analyzing result data generated by different interference, and comprises the steps of database creation, randomized grouping, statistical analysis, result obtaining and the like. The analysis method is used for performing comparative effectiveness analysis on clinically generated real data, confounding factors can be effectively controlled, an analysis result is high in extensionality, requirements on the sample size are low, and a plurality of result indexes can be simultaneously analyzed; the analysis method can be used for comparing the effectiveness and security of different clinical intervention methods or strategies, and new evidences for evidence-based medicine can be provided for clinical decision making.