Analysis of the current status of management in Investigator-Initiated Trials in China
10.3760/cma.j.cn113565-20231205-00136
- VernacularTitle:我国研究者发起的临床研究管理现况分析
- Author:
Yue ZHANG
1
;
Shuanghua XIE
;
Ningning ZHANG
;
Yingyuan ZHANG
;
Chenghong YIN
;
Wentao YUE
Author Information
1. 首都医科大学附属北京妇产医院/北京妇幼保健院 100026
- Keywords:
Investigator Initiated Trials;
Management;
Bibliometrics
- From:
Chinese Journal of Medical Science Research Management
2024;37(4):356-360
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To provide evidence for medical institutions to explore the standardized management in Investigator Initiated Trials (IIT) through understanding the problems and providing suggestions of IIT management in the past 10 years.Methods:The publication year, region, content, existing problems, and suggestions were abstracted and analyzed by Bibliometric analysis.Results:58 studies were included in the analysis from 12 regions, and the top three regions were Shanghai, Beijing, and Guangdong Province. There were 10 items of IIT management, including management status, ethical management, process management, information management, contract management, approval management, human genetic resource management, researcher management, multi-center management, and methodology system management. The problems and suggestions of each item of IIT management were summarized respectively.Conclusions:The imperfect supervision system of IIT has brought great difficulties to the management department. Medical institutions should clarify management points and risk points from the item of IIT management and take targeted measures to actively promote high-quality IIT research.
