Exploration and practice on Investigator－Initiated high－risk trial management at a pediatric hospital in Beijing
10.3760/cma.j.cn113565-20250415-00100
- VernacularTitle:北京某儿科医疗机构研究者发起的高风险临床研究管理探索与实践
- Author:
Yuguang LIANG
1
;
Chunyan GUO
1
;
Qian DING
1
;
Qian WANG
1
;
Meng ZHANG
1
;
Yi ZHANG
1
;
Peng GUO
1
Author Information
1. 国家儿童医学中心 首都医科大学附属北京儿童医院 临床研究中心，北京 100045
- Publication Type:Journal Article
- Keywords:
Clinical research;
Integrated management;
Improving quality and efficiency
- From:
Chinese Journal of Medical Science Research Management
2025;38(5):442-448
- CountryChina
- Language:Chinese
-
Abstract:
Objective:In response to the current situation where Investigator-Initiated Trial (IIT) management system of pediatric medical institutions in our country is inadequate and the management of high-risk projects needs to be strengthened, a pediatric hospital in Beijing has been selected as a pilot to develop a system and process suitable for IIT management. We aim to explore personalized management models for different types of research projects, especially high-risk ones, to improve the quality of pediatric IIT, reduce research risks, and enhance management efficiency.Methods:By analyzing the current management situation of high-risk pediatric IIT, optimization strategies were proposed to improve the internal IIT project management system and processes of the pilot unit, and effective management measures are promoted.Results:By revising the IIT project management system, improving the project application and approval processes, strengthening process quality control and personnel training, the risk control and quality supervision of such projects had been enhanced, thereby improving project quality and ensuring the rights and interests of research participants.Conclusions:After the pilot unit trialed a series of management measures for high-risk IIT projects, researchers' risk awareness has significantly increased, and project quality has been effectively improved. The Results provide a reference and model for peers in establishing management rules and also offer theoretical and practical foundations for improving the management system of high-risk clinical research.
