Practice of the Real-World Study on the Clinical Research of Traditional Chinese Medicine (TCM) / 世界科学技术-中医药现代化

ABSTRACT

With the development of modern technology and clinical practice,the classic randomized controlled trial nowadays cannot meet the researchers' needs for evidence with more reliable external validity,especially in the field of TCM.Meanwhile,real-world study (RWS) has been attracting more attention and at the forefront of clinical research all over the world for providing evidence in conformity with the real world condition.In this paper,we firstly described the basic concept of RWS,and then found that it was characterized by large representative samples,loose inclusion or exclusion criteria,allocation of interventions according to patients conditions and willingness,long-term follow-up,and clinically relevant endpoints.By analyzing the existing examples of RWS,we noted and discussed the promising future of RWS in TCM clinical research.Finally,we hope this paper will provide some inspiration for TCM researchers.