Analysis of the current situation, advantages and difficulties of standardized management of Investigator Initiated Clinical Trials
10.3760/cma.j.cn113565-20230712-00012
- VernacularTitle:研究者发起的临床研究规范化管理的现状、优势和难点分析
- Author:
Yingshuo HUANG
1
;
Xu ZUO
;
Yue LI
;
Lihan XING
;
Shuilong GUO
;
Zhenchang WANG
;
Shutian ZHANG
Author Information
1. 首都医科大学附属北京友谊医院科技处，北京 100050
- Keywords:
Investigator-Initiated Clinical Trials(IIT);
Standardized management;
Scientific review;
Supervision and inspection
- From:
Chinese Journal of Medical Science Research Management
2024;37(1):70-74
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To assess the current situation, advantages, and difficulties of standardized management in Investigator-Initiated Clinical Trials (IIT).Methods:This article summarized the requirements and policies for clinical research management, the development of clinical research domestically and internationally, the achievements and advantages of clinical research management development in China, and the main problems and difficulties with the standardized IIT management in China, and compiled the experiences and models of several medical institutions in IIT management.Results:While China has a large number of clinical medical publications and is ranked high in the world, the quality of the publications needs to be further improved. Domestic management requirements for IIT were gradually improving, providing a basis for medical institutions to implement standardized management throughout the lifecycle of IIT, and achieve certain progress. However, there were still challenges in the departmental divisions, the unification of management standards, whole-process management and quality control, the scientific review, high-risk project management, and registration.Conclusions:Drawing on the excellent experience of domestic medical institutions, measures including identifying a primary responsible department, establishing unified supervision and inspection standards, and implementing a whole life cycle management may help overcome the challenges in IIT management and improve the quality and efficiency of IIT management.
