Management status analysis of Investigator-Initiated Trials in Shandong provincial medical and health institutions
10.3760/cma.j.cn113565-20230309-00065
- VernacularTitle:山东省医疗卫生机构研究者发起的临床研究管理现状分析
- Author:
Linying MA
1
;
Jianmei JI
;
Honglei LI
;
Xinxin LU
;
Lili CAO
Author Information
1. 山东第一医科大学第一附属医院（山东省千佛山医院）科研处 山东省风湿免疫病转化医学重点实验室 山东省临床免疫转化医学实验室，济南 250014
- Keywords:
IITs;
Shandong provincial medical and health institutions;
Organizational management system
- From:
Chinese Journal of Medical Science Research Management
2023;36(5):395-400
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To analyze the current situation of Investigator-Initiated Trials in medical and health institutions in Shandong Province, the problems in the process of conducting clinical research, and put forward proposals for the establishment of a clinical research management system with effective supervision, sound systems and supporting services, taking into account the progress of the projects since the pilot work was carried out.Methods:A questionnaire was created, an online survey was conducted, a database was set up, a status analysis was conducted and a post-launch analysis of the progress of the pilot was carried out using the National Medical Research Registry Information System, culminating in recommendations using the literature summary method and empirical analysis.Results:Statistical analysis of the questionnaire found that 29.39% of the institutions have a dedicated clinical research management department, and 75.97% of the institutions have a management approach. 25.52%, 40.30%, and 43.07% of institutions established biobanks, clinical research centers, and follow-up centers. There was a statistically significant difference in the establishment of clinical research centers, biobanks, and follow-up centers in secondary and tertiary medical institutions ( P<0.05). The number of general clinical research projects filed, the number of submissions and the number of ethics committees filed in the filing system have all increased significantly after the pilot work, with growth percentages of 126%, 141% and 62% respectively. Conclusions:Shandong Province clinical research pilot work has begun to bear fruit, the current clinical research project still exists in the lack of special funding support, perfect service platform and system support and training system to be improved and other issues.
