Preliminary study of risk factors for Multi-center Investigator-Initiated Clinical Trial
10.3760/cma.j.cn113565-20240424-00107
- VernacularTitle:研究者发起的多中心临床研究风险管理要素的探讨
- Author:
Lingyan CHEN
1
;
Yining HE
1
;
Wenyuan DONG
1
;
Xian XIE
1
;
Hong ZHEN
1
;
Mochi LIU
1
;
Feng XU
1
Author Information
1. 上海交通大学医学院附属第九人民医院，上海交通大学中国医院发展研究院学科建设研究所，上海 200011
- Publication Type:Journal Article
- Keywords:
Investigator-Initiated Trial;
Multi-center clinical trials;
Risk assessment;
Risk management;
Quality management
- From:
Chinese Journal of Medical Science Research Management
2025;38(1):75-80
- CountryChina
- Language:Chinese
-
Abstract:
Objective:This study aims to explore the risk factors of Multi-center Investigator-Initiated Clinical Trials (MIITs), and provide a basis for developing study management strategies.Methods:The original draft of MIIT risk evaluation factors was determined through literature analysis and internal discussions of the research group. Thirty five experts were consulted using the Delphi method, and then the MIIT risk evaluation elements were finally determined. Analytic Hierarchy Process (AHP) was used to calculate the weights of each index.Results:The recovery rates of both rounds of expert consultation were 100%, and the degree of expert authority was 0.856. The study ultimately formed an MIIT risk evaluation framework consisting of three first-class indexes, twelve second-class indexes, and thirty-eight third-class indexes. The weight values of the first-class indexes (start-up period, implementation period, and summary period) were 0.209 8, 0.710 6, and 0.079 6, respectively. Meanwhile, the weight values of the second-class indexes and third-class indexes were determined.Conclusions:Exploring the risk evaluation factors of MIIT provides valuable insights into identifying critical risk points, which, in turn, contributes to enhancing MIIT management efficiency, research progress, and quality.
