儿科疾病中药真实世界研究设计指南

Guideline on Real World Study Design of Traditional Chinese Medicine for Pediatric Disease

《儿科疾病中药真实世界研究设计指南》为中国人口福利基金会立项课题,其目的是以临床价值为导向,重点阐述真实世界研究在儿科疾病中药研发中的适用范围、主要设计类型及技术要点,为中药的人用经验研究设计提供思路和方法。制定过程中先后成立指南工作组、起草专家组和定稿专家组,采用文献研究和共识会议方法,同时结合团队自身的儿童中药真实世界研究设计实践,最终研制完成。该《指南》的主要内容包括范围、术语和定义、概述、真实世界研究在儿童中药研发中的应用、儿童中药真实世界研究常用设计类型及技术要点、说明6部分,以期充分利用人用经验证据支持儿童中药研发,指导申办方和研究者(儿科医生)科学设计与实施真实世界研究。

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.