Challenges and countermeasures of Investigator-Initiated Trial of oncology
10.3760/cma.j.cn113565-20220315-00037
- VernacularTitle:肿瘤领域研究者发起的临床研究面临的挑战与对策
- Author:
Xinxin LU
1
;
Wenjiao JIAO
;
Linying MA
;
Lili CAO
Author Information
1. 山东第一医科大学第一附属医院（山东省千佛山医院） 山东省类风湿免疫病转化医学重点实验室，济南 250014
- Keywords:
Investigator-Initiated Trial(IIT);
Project management;
Challenges;
Countermeasures;
Oncology
- From:
Chinese Journal of Medical Science Research Management
2023;36(1):7-12
- CountryChina
- Language:Chinese
-
Abstract:
Objective:In order to put forward relevant measures and suggestions to improve the quality of the Investigator-Initiated Trials of oncology in medical institutions.Methods:Through literature research, comparative study, combined with the implementation and management of investigator initiated trials, the current status and challenges of the administration of these trials were analyzed.Results:Investigator-Initiated Trials of oncology become increasingly important. However, its quality is poor compared with Industry-Sponsored Trials due to insufficient funds and lack of effective supervision. Besides, four main challenges as follows were identified: lack of clinical research professionals, the quality concerns of ethical review in some institutions, insufficient funding for clinical research, and imperfect quality management system.Conclusions:Based on the actual needs of IITs of oncology, medical institutions should strengthen the talent cultivation, establish electronic information management platform, increase project support, strengthen scientific research supervision and deepen the awareness of risk prevention to improve the quality of investigator initiated trials.
