Traditional Chinese medicine (TCM) has a long history. In the process of fighting against diseases, TCM has formed a unique theoretical system and the way to think and diagnose. The holistic thinking, and the treatment according to syndrome differentiation are the most prominent characteristics of TCM, which matches with advanced medical concept and direction. The clinical efficacy has always been the basis for the advancement of TCM. However, issues such as the lagging behind of modern research on the evaluation of TCM curative effect, as well as lacking high-quality scientific research evidence, impede the development and promotion of the TCM toward the world. To address the above problems, recent progress in real-word study (RWS) has provided the opportunity for TCM researches, especially for the post-marketing evaluation of Chinese patent medicine (CPM). The formulation of this technical guidance for RWS of CPM is helpful to researchers in carrying out standardized, reasonable and scientific researches, to improve the quality of production and use of real-word evidence, and to promote the advancement of the TCM industry.
With the acceleration of global innovative drug development, selecting safe, effective, and cost-effective products from numerous drugs has posed new challenges for the decision-making process of medical insurance drug access and dynamic updating of insurance directory. Real-world data (RWD) provides a new perspective for evaluation of clinical and economic value of drugs, but there are still uncertainties regarding the scope, quality standards, and evidence categories of RWD that can be used. Based on the current status of domestic and international RWD supporting the assessment of the clinical and economic value of drugs, this paper, in collaboration with national RWD and healthcare experts, has developed the key considerations for using real-world data to evaluate the clinical and economic value of drugs. This paper first clarifies the scope of RWD that can be used to evaluate the clinical and economic value of drugs evaluate; secondly, provides specific requirements and guidance on data attribution, data governance, and quality standards for RWD; finally, summarizes the evidence categories of RWD supporting evaluate the clinical and economic value of drugs evaluate.