Asian Journal Of Social Pharmacy

Abstract: Objective To explore the application status of the “Technical Guidelines for Supporting the Development and Evaluation of Pediatric Drugs in Real-World Study (Trial)”, and to propose application strategies and practical and feasible guidance for better supporting the development and evaluation of pediatric drugs in China. Methods Through literature collection and data analysis, the existing issues of real-world study on pediatric drugs in China were found. Results and Conclusion Currently, there are some problems in the application process of the “Guidelines”, such as few sources and low quality of real-world data. Besides, the technology and methods of applying real-world evidence should be improved. Therefore, we should strengthen the collection of clinical data on pediatric drugs, accelerate the establishment of quality control standards for real-world data, and improve the application technology of real-world evidence. In addition, it is also necessary to promote the construction of a real-world evidence evaluation system to accelerate the research and evaluation of pediatric drugs and solve the shortage of drugs for children in China.

Key words: real-world study, pediatric drug, real-world data, application strategy