儿科临床研究协调员基本概况与困境分析及解决方案探讨

Basic profile and dilemma analysis of pediatric clinical research coordinators and discussion on the solution

近年来,我国儿科临床研究得到国家的大力扶持,儿科临床研究迫切需要儿科特色临床研究协调员(clinical research coordinator, CRC)的参与。但由于儿童群体的特殊性,儿科CRC在工作中可能面临着比成人临床研究更艰难的困境。本文总结了我国儿科CRC的基本概况,并结合个人工作经历,分析儿科领域CRC面临的困境并提出可能的解决方案,以期促进儿科CRC行业健康发展,从而保障临床试验的质量。

In recent years,pediatric clinical research has been strongly supported by the state in China.The participation of characteristic pediatric clinical research coordinator(CRC)in pediatric clinical research is urgently in need.However,due to the particularity of pediatric patients,pediatric CRC may face a higher dilemma than that of adult clinical research.This article summarizes the basic situation of pediatric CRC in China,analyzes the difficulties faced by pediatric CRC in combination with our own experience,and the possible solutions are put forward.We hope to promote the healthy development of pediatric CRC industry,which can further ensure the quality of clinical trials.