Traditional Chinese medicine（ TCM） has its unique advantages in the treatment of primary liver cancer.However

its clinical treatment effect on primary liver cancer has not been fully reflected

and method more suitable for evaluating Chinese medicine therapeutic effect is needed. In recent years

real-world study based on clinical data has received extensive attention. Based on the clinical electronic medical record of TCM

our research team carried out real-world research on primary liver cancer

and the key problems encountered in the evaluation of clinical efficacy of TCM

such as sample size estimation in research design

how to define the standard of complex intervention of TCM treatment

the selection of the outcome of primary liver cancer and the definition of the starting time of survival time

how to improve the data collection and data input quality during the research

the loss of data in the later follow-up period and the selection of the statistical analysis of the confounding factors. This paper analyzed the above issues and proposed corresponding solutions

to provide reference for the development of TCM clinical efficacy evaluation research based on real-world study.