Deepen the transparency concept of clinical research and strengthen whole-process supervision and administration of research

Chongya Dong, L. Yang, Hongbin Han, Xiaoyan Yan, C. Yao
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Abstract

Objective To acquire specific suggestions for improving the transparency of clinical research. Methods Summarize main challenges for transparency in clinical research, propose possible solutions. Results Currently the common practice of clinical research transparency is to promote study registration in the beginning phase, and reporting guildlines, data sharing in the end phase of the study. The main challenges identified in clinical research transparency are (1) lacking awareness of transparency among investigators, (2) poor data integrity and traceability of research data resulted by the ignorance of transparency during study implementation process. To face the challenges, investigator should be more proactive and related research administration should be streamlined. Conclusions To improve the transparency of clinical research, better understandings of the concept of clinical research transparency for investigators and whole-process supervision from the administrative aspect should be strengthened. Furthermore, advanced information technology should be adopted to construct a hospital-based source data platform for complete clinical research process management, it helps in promoting research data quality and could become a suitable tool for clinical research administration in hospitals. Ultimately, full research transparency would be achieved. Key words: Clinical research; Transparency; Source data; Process supervision; Traceability
深化临床研究透明化理念,加强研究全过程监督管理
目的为提高临床研究的透明度提供具体建议。方法总结临床研究透明度面临的主要挑战,提出可能的解决方案。结果目前临床研究透明度的常见做法是在研究开始阶段促进研究注册,在研究结束阶段报告指导方针和数据共享。临床研究透明度方面的主要挑战是(1)研究人员缺乏透明度意识,(2)研究实施过程中对透明度的无知导致数据完整性和研究数据的可追溯性较差。面对这些挑战,研究者应该更加积极主动,相关的研究管理应该精简。结论为了提高临床研究的透明度,应加强对研究人员临床研究透明度概念的理解,并从管理层面加强全过程监督。此外,应采用先进的信息技术构建一个基于医院的源数据平台,用于完整的临床研究过程管理,这有助于提高研究数据质量,并可能成为医院临床研究管理的合适工具。最终,将实现充分的研究透明度。关键词:临床研究;透明度;源数据;过程监督;可追溯性
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