Exploration into the current status and management system construction of Investigator-Initiated Clinical Trials in a stomatology institution
10.3760/cma.j.cn113565-20240826-00201
- VernacularTitle:某口腔专科医疗机构研究者发起的临床研究现状及管理体系建设探讨
- Author:
Lin ZHANG
1
;
Yan LIU
1
;
Mingming XU
1
;
Ruirui SHI
1
;
Jianwei HU
1
Author Information
1. 北京大学口腔医院，北京 100081
- Publication Type:Journal Article
- Keywords:
Stomatology institutions;
Investigator-Initiated Clinical Trials;
Full lifecycle;
Management system
- From:
Chinese Journal of Medical Science Research Management
2025;38(2):145-149
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To analyze the current status of investigator-initiated clinical trials in a stomatology institution and explore establishing a suitable management system.Methods:By analyzing the data of the Medical Research Registration and Filing System of the National Health Commission and using the literature review and experience analysis methods, this study proposed key points for constructing the project management system.Results:The number of IITs in stomatology institutions increased over the years, with a relatively small overall size and short execution cycles. Young and middle-aged medical personnel were the main executors of the projects. The research mainly took the form of publishing papers and applying for patents. Based on the four dimensions of demand, countermeasures, cycle, and management, integrating support platforms such as methodology clinic, data platform, and transformation clinic, and combining supervision and inspection to explore constructing an IIT whole lifecycle management system.Conclusions:The IIT whole lifecycle management system was helpful for standardized project implementation and clinical research talent cultivation. In the future, it can refine management processes, improve management efficiency, and lay the foundation for higher-level clinical research.
