The international experiences of Investigator-initiated Clinical Trials and implications
10.3760/cma.j.cn113565-20200817-00274
- VernacularTitle:研究者发起的临床研究国际经验及对我国的启示
- Author:
Huifang ZHANG
1
;
Lingling YU
;
Bi ZHANG
;
Pengjun ZHANG
Author Information
1. 北京医院科研处 国家老年医学中心 中国医学科学院老年医学研究院 100730
- Keywords:
Investigator-initiated Clinical Trial;
International;
Experience;
Revelation
- From:
Chinese Journal of Medical Science Research Management
2021;34(3):235-240
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To introduce the experience of international Investigator- initiated Clinical Trials (IIT), provide suggestions for the construction of IIT management system in China. Methods:Applying the literature review research methodologies to analyze the document materials, five aspects including the funding source, technical support, personnel training, management mechanism and policy assurance were analyzed.Comparison was conducted to identify possible problems existed in Chinese IIT, and further explore possible lessons that we can learn in Chinese context.Results:Identified problems of Chinese IIT include insufficient funds, unsound scientific research design, imperfect data information system, lack of standard training for researchers, as well as the urgent need for more optimized whole-process management, quality control, and policy support.Conclusions:Suggested series of measurements that including expand the funding sources, improve the construction of scientific steering committee, improve the construction of data information platform at the national level, standardize the training of researchers, and update the operation mechanism and also the regulatory requirement are proposed to enhance the IIT research quality, as well as the IIT management.
