Exploration on Construction of the Investigator Initiate Trial Management System
10.3870/j.issn.1004-0781.2024.10.014
- VernacularTitle:研究者发起的临床研究管理体系建设探索
- Author:
Yu FENG
1
;
Zhonglin CHEN
;
Rong LI
Author Information
1. 上海市胸科医院/上海交通大学医学院附属胸科医院临床研究中心,上海 200030
- Keywords:
Medical science and technology innovation;
Investigator initiate trial;
Management system
- From:
Herald of Medicine
2024;43(10):1620-1624
- CountryChina
- Language:Chinese
-
Abstract:
Objective To adapt to the requirements of medical technology innovation under the new situation.To explore the establishment of a scientific,standardized,and reasonable management institution and system.It aims to actively promote the development of Investigator Initiate Trials(IITs)in medical and health institutions.Methods By conducting a literature review,policy interpretation,and examing work practices,this study identified the pain points and difficulties in IIT management.It sorted out the core requirements and elements needed for effective IIT management and proposed measures.Results The study proposed the development of five support systems for IIT management.A functional responsibility system for implementing classified and tiered management of IITs with clear delineation of responsibilities and authority;A quality supervision system that introduces a third-party co-management mechanism to fill the gaps of IIT quality management in the three-level quality control system;A fund support system that reduces or waives the hospital management fees for IITs,and incorporate the IIT undertaking into the annual evaluation metrics for optimized SMO;A collaborative innovation system that connect with external enterprises and coordinates internal departments to jointly promote the efficient operation of IITs;A risk early warning system that establishes IIT risk assessment criteria and conducts real-time dynamic supervision,strengthening IIT data management,and ensuring IIT data security.Conclusions Currently,IIT management generally lacks sufficient attention in China,and there is no complete framework or practice.By constructing the five IIT system construction scheme.It is conducive to optimizing the process,improving efficiency,ensuring quality and reducing risk,which has certain reference significance for the improvement and development of IIT management.
