Revision and reflection of the Administrative Measures for Investigator-initiated Clinical Research in Medical and Health Institutions
10.3760/cma.j.cn113565-20240928-00256
- VernacularTitle:对《医疗卫生机构开展研究者发起的临床研究管理办法》修订和实施的思考
- Author:
Jiyin ZHOU
1
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
- Publication Type:Journal Article
- Keywords:
Investigator-Initiated Trial;
Medical and health institutions;
Administrative measures;
Reflection
- From:
Chinese Journal of Medical Science Research Management
2025;38(2):88-93
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To analyze the Administrative Measures for Investigator- initiated Clinical Research in Medical and Health Institutions and to provide suggestions for its implementation. Methods:By comparing the 2021 trial version with the official version of the Administrative Measures for Investigator- initiated Clinical Research in Medical and Health Institutions issued by the National Health Commission, the State Administration of Traditional Chinese Medicine and the National Administration for Disease Control and Prevention on October 18, 2024, the new, modified and deleted contents of the Administrative Measures for Investigator-initiated Clinical Research in Medical and Health Institutions were sorted out, summarized and interpreted. Measures for the Administration of Investigator- initiated Clinical Research by Medical and Health Institutions. Results:The Administrative Measures for Investigator-initiated Trial in Medical and Health Institutions remains unchanged from its trial version in terms of structure, with 7 chapters and 49 articles, and from 6, 346 words to 6, 520 words. In order to better regulate the rapidly developing investigator-initiated trial in China, and taking into account the current situation of investigator-initiated trial in China, the results of the pilot programme over 3 years and the feedback from the study, the content of the Administrative Measures for Investigator-initiated Trial in Medical and Health Institutions is more in line with the actual situation, and a lot of new details and specific requirements have been added. The main revisions include the joint issue of 3 administrators, which governs medical and health institutions in all aspects; updating the terms and contents with the latest regulations about ethics review; adjusting the scope of scientific review, which is only required for interventional studies; strictly managing observational studies beyond the minimum risk; cancelling the qualifications of medical and health institutions that as sub-centres in multicentre of superscope investigator-initiated trial; emphasizing that medical and health institutions should give the necessary support of manpower and financial resources, encourages the implementation of full life-cycle management of source data in conjunction with actual practice, specifies the adoption of a unified system number to manage matters after the completion of the trail, and emphasizes the declaration of conflict of interest when releasing trail results.Conclusions:In order to effectively implement the Administrative Measures for Investigator-initiated Clinical Research in Medical and Health Institutions shall accelerate the establishment of a clinical research management system, ensure sufficient manpower and financial resources to support clinical research, strengthen the training of Investigator-Initiated Trial management, research, scientific review, ethical review and other personnel, and provide investigators with scientific research outpatient services, implement scientific review based on risk levels, and make it clear that unmarketed products cannot be used in investigator-initiated trials. Refine the qualifications of medical and health institutions participating in off-label investigator-initiated trial.
