Discussion on critical issues in the construction of management and supporting system of Investigator-Initiated Trials in pediatrics
10.3760/cma.j.cn113565-20210201-00020
- VernacularTitle:研究者发起的儿科临床研究项目管理体系建设思考
- Author:
Jinxia WANG
1
;
Ziyang CAO
;
Lin ZOU
;
Chunxia WANG
;
Guangjun YU
Author Information
1. 上海市儿童医院临床研究中心 上海交通大学医学院临床研究中心儿童医院分中心 200062
- Keywords:
Investigator-Initiated Trial;
Clinical Research Units;
Management System;
Platform Construction;
Children
- From:
Chinese Journal of Medical Science Research Management
2022;35(1):42-46
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To explore the critical issues in the construction of management and supporting system of Investigator-Initiated trials (IIT) in pediatrics.Methods:Through summarizing related literature and considering the current status of pediatric clinical research, the critical issues in the construction of management and support system, for instance, the responsibility, training model, and performance evaluation in Europe and U. S. were evaluated, decision-making suggestions were put forward based on domestic pediatric IIT management system.Results:Besides IIT, clinical trials on children′s drugs are also supported by the pediatric clinical research management system in Europe and U. S.. The supporting service covers research consultation, ethical review, research design, trial implementation, patient education, risk control, and investigator training. The organizational structure and management system are relatively mature. Clinical trials are the majority of clinical research in children′s hospitals in China. Main issues identified in the construction of the management and supporting system include ethical review for pediatric clinical research, professional investigator training, multicenter cooperation scheme, performance assessment, and incentive strategies.Conclusions:Taking account into the current status of pediatric IIT in China, it is urgent to accelerate the training of pediatric investigators, set up standard IIT project management team, build the professional project management platform and Electronic Data Capture System, and promote the transformation of research outcomes. Finally, the whole process management of pediatric IIT will be developed to facilitate the development of pediatric medicine.
