查看更多>>摘要：目的 分析临床医生开展临床研究的意愿及其影响因素，为科学、有效地促进临床研究开展，提高临床医生的积极性提供参考依据。 方法 选取天津市某三甲医院作为问卷调查单位，采用单纯随机抽样的方法选取临床医生，采用SPSS 26.0软件进行Wilcoxon秩和检验、Kruskal-Wallis秩和检验和广义线性模型分析。 结果 调查的273名临床医生开展临床研究意愿评分值为5.00。多因素分析结果显示：与"≥31年"相比，工作时间"≤10年"、"11～20年"、"21～30年"与开展意愿得分的关联差异有统计学意义，且均呈正相关；与"清楚"医院医学伦理审查流程相比，"了解一些"医院医学伦理审查流程与开展意愿得分的关联差异有统计学意义，且呈负相关；与"有空闲时间"相比，"临床工作繁忙没有时间"与开展意愿得分的关联差异有统计学意义，且呈负相关；与"投入时间能得到成果"相比，"投入大量时间和精力短期无法取得成果"与开展意愿得分的关联差异有统计学意义，且呈负相关；与"愿意"参加科研培训相比，"无所谓"参加科研培训，"不愿意"参加科研培训与开展意愿得分的关联差异有统计学意义，且均呈负相关。 结论 临床医生开展临床科研的意愿受诸多因素的影响，医院应重视青年人才培养、开展科研培训、搭建科研帮扶团队从而提高科研积极性。 Objective To analyze the willingness of clinicians to carry out clinical research and its influencing factors, and to provide a reference basis for scientifically and effectively promoting clinical research and improving the enthusiasm of clinicians. Methods A grade A tertiary hospital in Tianjin was selected as a questionnaire unit, and clinicians were selected by simple random sampling. SPSS26.0 was utilized for the Wilcoxon rank sum test, Kruskal-Wallis H test, and generalized linear model analysis. Results The score of willingness to carry out clinical research among 273 clinicians was 5.00. The results of multivariate analysis showed that, in terms of working time, compare with ″≥31years″, ″≤10years″, ″11~20years″, and ″21~30years″ had statistical significance in association with the scores of willingness to carry out clinical researchs, all of which were positively correlated compared with the ″clear″ awareness of hospital medical ethics review process, ″knowing some″ had a statistical significance in association with the willingness scores with a negative correlation compared with ″having free time″, the association between ″busy clinical work and no time″ and the willingness scores was statistically significant, and showed a negative correlation compared with ″time devoting can get results″, the association between ″a lot of time and efforts can not achieve results in a short time″ and the score of willingness was statistically significant, and was negatively correlated compared with ″willing″ to participate in scientific research and training, ″it does not matter″ and ″unwilling″ showed statistical significance in association with the willingness scores, and negatively correlated. Conclusions The willingness of clinicians to conduct clinical research was affected by multiple factors. Hospitals should emphasize the cultivation of young talents, carry out research training, and build research support teams to improve the enthusiasm for research.
查看更多>>摘要：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.
查看更多>>摘要：目的 分析研究者发起的临床研究(IIT)规范化管理的现状、优势和难点。 方法 总结归纳国内外临床研究管理要求和政策规定、国内外临床研究发展情况、中国临床研究管理发展的成绩和优势、研究者发起的临床研究规范化管理的主要问题和难点，并汇总了一些医疗机构在IIT管理方面的经验和模式。 结果 中国临床医学论文发表数量较多且在全球排名靠前，但高质量论文数量有待进一步提升。国内关于IIT的管理要求正在逐步完善，为医疗机构落实IIT全生命周期的规范化管理提供了依据，并且取得了一定成效，但在管理部门划分、管理标准统一、全流程管理和质量管理、科学性审查、高风险项目管理及注册备案等方面仍存在一些管理难点。 结论 借鉴国内医疗机构的优秀经验，通过落实主责部门、建立统一监查标准、落实全生命周期管理等方式，解决IIT管理的难点，提升IIT的管理质量和效率。 Objective To assess the current situation, advantages, and difficulties of standardized management in Investigator-Initiated Clinical Trials (IIT). Methods This article summarized the requirements and policies for clinical research management, the development of clinical research domestically and internationally, the achievements and advantages of clinical research management development in China, and the main problems and difficulties with the standardized IIT management in China, and compiled the experiences and models of several medical institutions in IIT management. Results While China has a large number of clinical medical publications and is ranked high in the world, the quality of the publications needs to be further improved. Domestic management requirements for IIT were gradually improving, providing a basis for medical institutions to implement standardized management throughout the lifecycle of IIT, and achieve certain progress. However, there were still challenges in the departmental divisions, the unification of management standards, whole-process management and quality control, the scientific review, high-risk project management, and registration. Conclusions Drawing on the excellent experience of domestic medical institutions, measures including identifying a primary responsible department, establishing unified supervision and inspection standards, and implementing a whole life cycle management may help overcome the challenges in IIT management and improve the quality and efficiency of IIT management.
查看更多>>摘要：目的 探讨提高医院伦理审查能力的路径和方法，保障伦理审查的质量和效率。 方法 通过查阅文献，结合样本医院伦理委员会建设与伦理审查工作的实践经验，分析我国伦理审查的现状，深入剖析医院伦理审查工作存在的主要问题。 结果 通过实行归口管理、优化工作流程，建立应急制度、开通绿色通道，优化委员构成、加强伦理培训与考核，统一文件清单、加强形式审查，加强预审沟通、灵活审查方式，加大宣传力度、提升伦理意识等举措，能有效提高伦理审查质量和效率。 结论 明确责任分工，强化多部门联动，能有效提高伦理审查效率；优化伦理委员结构，加强委员培训与考核，能有效提升伦理委员审查能力；统一文件清单，优化工作流程和审查方式，能有效缩短伦理审查周期。建议进行持续伦理培训和考核评价、运用信息化平台系统实现动态监管、从国家层面建立对伦理委员会认证制度和考核机制，以促进伦理审查能力进一步提升。 Objective To explore the ways and methods to improve the ability of hospital ethical review and ensure the quality and efficiency of ethical review. Methods By consulting the literature and combining the practical experience of the construction of the ethics committee and the ethical review work in the hospital, analyze the present situation of ethical review in our country, and deeply analyze the main problems existing in the work of ethical review in hospitals. Results The quality and efficiency of ethical review can be effectively improved by implementing centralized management, optimizing work processes, establishing emergency response systems, opening green channels, optimizing the composition of committee members, strengthening ethical training and assessment, establishing emergency response systems, opening green channels, strengthening pre-review communication, establishing emergency response systems, opening green channels, strengthening formal review, increasing publicity, and improving ethical awareness. Conclusions Clarifing the division of responsibilities and strengthen multi-department interaction can effectively improve the efficiency of ethics review. Optimizing the structure of ethics committee, strengthen the training and assessment of members, can effectively enhance the ability of ethics committee review. Unifing the list of documents, optimizing the work flow and the way of examination can effectively shorten the period of ethical examination. It is suggested that continuous ethical training and assessment should be carried out, that an information-based platform system should be used to achieve dynamic supervision, and that a certification system and assessment mechanism for ethics committees should be established at the national level, to promote the improvement of the ability of ethical review.
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