Exploring the construction of a digitised whole－process management platform for paediatric Investigator－Initiated Clinical Trials
10.3760/cma.j.cn113565-20250311-00060
- VernacularTitle:儿科研究者发起的临床研究数字化全流程管理平台建设探索
- Author:
Hongyang ZHANG
1
;
Zijun YAN
1
;
Jinxia WANG
1
;
Ziyang CAO
1
;
Min CHEN
1
;
Lin ZOU
1
Author Information
1. 上海市儿童医院/上海交通大学医学院附属儿童医院，上海 200062
- Publication Type:Journal Article
- Keywords:
Investigator-Initiated Trial;
Digitised management;
Whole-process management;
Platform construction;
Paediatrics
- From:
Chinese Journal of Medical Science Research Management
2025;38(5):425-430
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To explore the construction requirements and solutions for a digital full-process management platform for Investigator-Initiated Trials (IIT) in pediatrics in China.Methods:By reviewing literature, the current status and highlights of pediatric IIT digital management systems in Europe and the United States were analyzed. The challenges faced in building a digital full-process management platform for pediatric IIT in China were summarized. The exploration and implementation achievements of our hospital in platform construction were introduced, and future construction priorities were proposed based on practical considerations.Results:The construction and application of digital full-process management platforms for pediatric IIT in Europe and the United States were relatively mature, providing comprehensive digital support for pediatric IIT research, ranging from project management to research design implementation, multi-center data interoperability, and personnel training. In China, the pediatric IIT digital management platform was still under construction, with main challenges including the formulation of construction plans based on hospital-specific conditions, data standardization, and remote recruitment and follow-up platforms.Conclusions:Considering the current status of pediatric IIT digital full-process management systems both domestically and internationally, efforts should be made to further strengthen data standardization, remote subject management, and digital pediatric IIT training from both policy and technical perspectives. This will provide one-stop services and management for projects and researchers, promoting the development of pediatric medical research.
