Problem and management strategy exploration of the investigator initiated out-of-range trial
10.3760/cma.j.cn113565-20230909-00062
- VernacularTitle:研究者发起的超范围临床研究管理策略探析
- Author:
Yuanyuan LI
1
;
Lanlan HU
;
Jin CHEN
;
Yan WANG
;
Jianyun ZHOU
Author Information
1. 陆军军医大学第二附属医院临床医学研究中心，重庆 400037
- Keywords:
Investigator-Initiated Chinical Trial(IIT);
Out-of-range;
Risk prevention;
Management strategy
- From:
Chinese Journal of Medical Science Research Management
2024;37(1):66-69
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To analyze the problems and risk factors of the investigator initiated out-of-range trial, propose countermeasures and suggestions, and provide reference for improving project standardization and quality, and preventing research risks.Methods:Through literature analysis and field research, combined with personal work experience, this study sorted and analyzed the problems in the regulation of out-of-range IIT conducted in hospital, and proposed countermeasures.Results:Through analysis, it was found that the current out-of-range IIT trial in China faces 5 problems: imperfect management regulations, incomplete IIT management organizational system in medical institutions, insufficient scientificity of research protocols, insufficient ethical review, and insufficient research funds.Conclusions:Out-of-range IIT is of great significance in promoting pharmaceutical innovation. Standardized management of such projects requires the efforts of regulatory authorities, medical institutions, and ethics committees, as well as the continuous improvement of researchers' awareness and research capabilities to promote the orderly, high-quality, and rapid development of IIT. Based on the above analysis, this article proposed countermeasures and suggestions: at the national level, summarize practical experience from various regions as soon as possible, improve IIT management regulations and technical guidelines; establishing clinical research and design guidance departments in medical institutions and strengthening scientific review; the ethics committee formulates ethical review standards and processes for out-of-range IIT projects to enhance review capabilities; establish a normalized clinical research training mechanism in hospitals; expand and standardize the channels for IIT funding.
