Problem and management strategy exploration of the investigator initiated out-of-range trial
扫码查看
点击上方二维码区域，可以放大扫码查看
原文链接
万方数据
目的 通过分析研究者发起的超范围临床研究(即超范围IIT)存在的问题与风险因素，提出对策建议，为提升项目规范性和质量、防范研究风险提供借鉴。 方法 通过文献分析与实地调研等方法，结合自身工作体会，对医院超范围IIT科研监管中存在的问题进行梳理分析，提出对策建议。 结果 通过梳理分析发现，当前我国超范围IIT研究面临管理法规不健全、医疗卫生机构IIT管理组织体系不完善、研究方案科学性不5、伦理审查不充分和研究经费不足5个方面的问题。 结论 超范围IIT对促进医药创新有重要意义，做好此类项目的规范管理，需要监管部门、医疗机构和伦理委员会的多方努力，也需要研究者不断提高认识和研究能力，推动IIT有序、高质量快速发展。通过以上分析，本文提出五个方面的对策建议：国家层面尽快总结各地实践经验，完善IIT管理法规和技术指南；医疗机构设立临床研究设计指导部门、强化科学性审查；伦理委员会制定超范围IIT项目的伦理审查标准与流程，提高审查能力；医院建立常态化临床研究培训机制；拓展和规范IIT经费筹措渠道。 Objective To analyze the problems and risk factors of the investigator initiated out-of-range trial, propose countermeasures and suggestions, and provide reference for improving project standardization and quality, and preventing research risks. Methods Through literature analysis and field research, combined with personal work experience, this study sorted and analyzed the problems in the regulation of out-of-range IIT conducted in hospital, and proposed countermeasures. Results Through analysis, it was found that the current out-of-range IIT trial in China faces 5 problems: imperfect management regulations, incomplete IIT management organizational system in medical institutions, insufficient scientificity of research protocols, insufficient ethical review, and insufficient research funds. Conclusions Out-of-range IIT is of great significance in promoting pharmaceutical innovation. Standardized management of such projects requires the efforts of regulatory authorities, medical institutions, and ethics committees, as well as the continuous improvement of researchers' awareness and research capabilities to promote the orderly, high-quality, and rapid development of IIT. Based on the above analysis, this article proposed countermeasures and suggestions: at the national level, summarize practical experience from various regions as soon as possible, improve IIT management regulations and technical guidelines establishing clinical research and design guidance departments in medical institutions and strengthening scientific review the ethics committee formulates ethical review standards and processes for out-of-range IIT projects to enhance review capabilities establish a normalized clinical research training mechanism in hospitals expand and standardize the channels for IIT funding.
Objective To analyze the problems and risk factors of the investigator initiated out-of-range trial, propose countermeasures and suggestions, and provide reference for improving project standardization and quality, and preventing research risks. Methods Through literature analysis and field research, combined with personal work experience, this study sorted and analyzed the problems in the regulation of out-of-range IIT conducted in hospital, and proposed countermeasures. Results Through analysis, it was found that the current out-of-range IIT trial in China faces 5 problems: imperfect management regulations, incomplete IIT management organizational system in medical institutions, insufficient scientificity of research protocols, insufficient ethical review, and insufficient research funds. Conclusions Out-of-range IIT is of great significance in promoting pharmaceutical innovation. Standardized management of such projects requires the efforts of regulatory authorities, medical institutions, and ethics committees, as well as the continuous improvement of researchers' awareness and research capabilities to promote the orderly, high-quality, and rapid development of IIT. Based on the above analysis, this article proposed countermeasures and suggestions: at the national level, summarize practical experience from various regions as soon as possible, improve IIT management regulations and technical guidelines establishing clinical research and design guidance departments in medical institutions and strengthening scientific review the ethics committee formulates ethical review standards and processes for out-of-range IIT projects to enhance review capabilities establish a normalized clinical research training mechanism in hospitals expand and standardize the channels for IIT funding.
万方数据
