Establishing the pediatric clinical medicine comprehensive evaluation system: Exploration of the method and path / 国际药学研究杂志

ABSTRACT

Due to the weak foundation of clinical trials, the pre-market data of pediatric medicine is insufficient. Therefore, a comprehensive evaluation system of pediatric clinical medicine is urgently needed to safeguard the children’s medication safety. This article provides the method and builds path to establish the comprehensive evaluation system from the aspects of biulding organizational structure, operational process and evaluation methodology, respectively. Further, based on the concept of "Evidence-based or otherwise evidence-created", and following the example of "Mini-Sentinel" of the United States, the big data in medicine can be used to overcome the "Evidence-created" difficulty in the evaluation of pediatric medication. Thus more extensive comprehensive evaluation can be made through collecting the clinical data generated from the real world for the pediatric medication. In the future, the comprehensive evaluation system of pediatric clinical medicine established on the basis of big data can be linked to the "Precision Medicine" Project in our country, the evaluation bases can be the "Mini-Sentinel" to collect big medical data and biological samples, thus to bring a steady flow of power for promoting the pediatric medicine active surveillance and pediatric precision medicine, and finally to safeguard the children’s health in our country.