《兒科疾病中藥真實世界研究設(shè)計指南》為中國人口福利基金會立項課題，其目的是以臨床價值為導向，重點闡述真實世界研究在兒科疾病中藥研發(fā)中的適用范圍、主要設(shè)計類型及技術(shù)要點，為中藥的人用經(jīng)驗研究設(shè)計提供思路和方法。制定過程中先后成立指南工作組、起草專家組和定稿專家組，采用文獻研究和共識會議方法，同時結(jié)合團隊自身的兒童中藥真實世界研究設(shè)計實踐，最終研制完成。該《指南》的主要內(nèi)容包括范圍、術(shù)語和定義、概述、真實世界研究在兒童中藥研發(fā)中的應用、兒童中藥真實世界研究常用設(shè)計類型及技術(shù)要點、說明6部分，以期充分利用人用經(jīng)驗證據(jù)支持兒童中藥研發(fā)，指導申辦方和研究者（兒科醫(yī)生）科學設(shè)計與實施真實世界研究。

Guideline on Real World Study Design of Traditional Chinese Medicine for Pediatric Disease is funded by China Population Welfare Foundation. The purpose of this paper is to expound the application, main design types and technical points of real-world research (RWS) in the research and development of traditional Chinese medicine for pediatric diseases, it provides the idea and method for the research and design of the human use experience of traditional Chinese medicine. During the development process, the guideline working group, drafting expert group and final drafting expert group were set up successively, using the method of literature research and consensus meeting, and combining with the team's own design practice of RWS for children, final Guide to the final form of the final draft. The main contents of the guide include scope, terms and definitions, overview, application of real-world research in research and development of Chinese medicine for children, common design types and technical points for real-world research of Chinese medicine for children, and six parts of an explanation, the purpose of this study is to make full use of human experience evidence to support the research and development of Chinese traditional medicine for children, and to guide the sponsors and researchers/pediatricians in scientific design and implementation of real world study.

中國人口福利基金會婦女兒童關(guān)愛工程計劃資助項目（GNB-6-20210304-68）