临床和转化研究报告标准

Fengyu Zhang, C. Hughes
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引用次数: 2

摘要

报告临床和临床前研究结果的透明度对于公正的出版物至关重要。资助机构、出版商和监管机构有责任倡导和实施严格设计的报告标准。虽然个别研究方案可能包括这些标准,但各自出版物中报告的项目往往不一致或缺乏透明度。这篇社论旨在为临床研究结果的报告提供一些具体的指导方针,并要求严格的研究设计标准。我们建议临床研究报告应包括研究设计和分析计划的充分信息,包括数据处理、质量保证和用于严格统计分析或建模的适当方法。出版物与原始研究设计之间的任何差异都应予以披露和讨论。此外,应该利用重复测量和统计模型分析结果的最新进展来获得无偏估计。最后,我们简要讨论了在临床研究中报告真实世界证据的一些问题。
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Reporting Standards for Clinical and Translational Research
Transparency in reporting the results of clinical and preclinical research is critical for unbiased publications. Funding agencies, publishers, and regulators have the responsibility to advocate and implement reporting standards for rigorous design. While individual study protocols may have included these standards, the items reported in the respective publications have often been inconsistent or lack transparency. This editorial intends to provide some specific guidelines for reporting results of clinical research with standards required for rigorous study design. We recommend that reporting clinical research should include sufficient information on study design and analysis plan that contains data processing, quality assurance, and appropriate methods used for rigorous statistical analysis or modeling. Any discrepancy between publications and original study design should be disclosed and discussed. Additionally, recent advances in the analysis of outcome with repeated measurements and statistical modeling should be employed to obtain unbiased estimates. Finally, we briefly discuss some issues reporting real-world evidence in clinical research.
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