Clinical efficacy is the foundation of the existence and development of traditional Chinese medicine（ TCM）. Constructing clinical efficacy evaluation methods that follow evidence-based design

and suitable for TCM characteristics and scientific norms is a key issue to be solved urgently. Randomized controlled trials（ RCTs） are the representative of traditional clinical research methods and the cornerstone of evidence-based evidence

but the design methods are difficult to integrate with TCM characteristics. Real world study（ RWS） is in line with the characteristics of individualized diagnosis and treatment of TCM and overall efficacy evaluation

and it is expected to open a new path for the evaluation of TCM syndrome differentiation. The key aspects of the implementation of TCM RWS include clinical protocols

TCM terminology standardization

medical record template design

data collection

data warehouse construction

data analysis

quality control and ethical review. Under the premise of not relying on syndrome differentiation and treatment

the clinical data of TCM actual diagnosis and treatment is used

through strict normative design

measurement and evaluation

to obtain high-quality real-world evidence

which can provide scientific basis for clinical application. Meanwhile

RWS is an important continuation and supplement of RCT. It is necessary to select appropriate research methods around specific scientific issues

and continuously optimize and improve.