Therapeutic effect is the foundation of the existence and development of traditional Chinese medicine（TCM）. TCM efficacy is mainly reflected through cases and experiences

which has restricted the inheritance and innovation. Thus

how to integrate concepts and methods of modern clinical epidemiological and evidence-based medicine to construct clinical therapeutic effects evaluation method suitable for the characteristics of TCM and in line with international norms is a vital scientific problem to be solved urgently. For this problem

this paper sorts out the characteristics and connotation of ancient TCM evidence and its influencing factors

explores the promotion and dilemma of modern scientific research methods to produce high-quality TCM evidence

and clearly proposes that the establishment of the clinical therapeutic effects evaluation methods that truly conforms to the characteristics of TCM is an essential challenge. In the context of data-driven

new technologies represented by real-world study

big data

artificial intelligence are expected to provide ideas and methods for innovative TCM clinical therapeutic effects evaluation methods.