内分泌与代谢领域期刊对临床试验报告中数据共享声明的要求：一项调查

Request of endocrinology and metabolism journals for data sharing statements in clinical trial reports: a survey.

作者信息

Liu Yingxin, Chen Bo, Zhang Jingyi, Bai Xuerui, Kang Lili, Li Wenli, Li Guowei

机构信息

Center for Clinical Epidemiology and Methodology (CCEM), The Affiliated Guangdong Second Provincial General Hospital of Jinan University, Guangzhou, China.

Department of Endocrinology, The Affiliated Guangdong Second Provincial General Hospital of Jinan University, Guangzhou, China.

出版信息

Front Med (Lausanne). 2025 May 21;12:1518399. doi: 10.3389/fmed.2025.1518399. eCollection 2025.

DOI:10.3389/fmed.2025.1518399

PMID:40470047

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12133921/

Abstract

BACKGROUND

To enhance reproducibility and transparency, the International Committee of Medical Journal Editors (ICMJE) required that all trial reports submitted after July 2018 must include a data sharing statement (DSS). Accordingly, emerging biomedical journals required trial authors to include a DSS in submissions for publication if trial reports were accepted. Nevertheless, it was unclear whether endocrinology and metabolism journals had this request for DSS of clinical trial reports. Therefore, we aimed to explore whether endocrinology and metabolism journals requested DSS in clinical trial submissions, and their compliance with the declared request in published trial reports.

METHODS

Journals that were from the category of "Endocrinology & Metabolism" defined by Journal Citation Reports (JCR, as of June 2023) and published clinical trial reports between 2019 and 2022, were included for analysis. The primary outcome was whether a journal explicitly requested a DSS in its manuscript submission instructions for clinical trials, which was extracted and verified in December 2023. We also evaluated whether these journals indeed included a DSS in their published trial reports that were published between December 2023 and May 2024.

RESULTS

A total of 141 endocrinology and metabolism journals were included for analysis, among which 125 (88.7%) requested DSS in clinical trial submissions. Journals requesting DSS had a significantly lower JCR quartile and higher impact factor when compared with those journals without DSS request. Among the 90 journals requesting DSS, 14 (15.6%) journals indeed did not publish any DSS in their published trial reports between December 2023 and May 2024.

CONCLUSION

Over 10% of endocrinology and metabolism journals did not request DSS in clinical trial submissions. More than 15% of the journals declaring to request DSS from their submission instructions, did not publish DSS in their published trial reports. More efforts are needed to improve the practice of endocrinology and metabolism journals in requesting and publishing DSS of clinical trial reports.

摘要

背景

为提高可重复性和透明度，国际医学期刊编辑委员会（ICMJE）要求2018年7月之后提交的所有试验报告必须包含一份数据共享声明（DSS）。因此，新兴生物医学期刊要求，如果试验报告被接受，试验作者在投稿发表时须包含一份DSS。然而，尚不清楚内分泌与代谢领域的期刊对于临床试验报告的DSS是否有此要求。因此，我们旨在探究内分泌与代谢领域的期刊在临床试验投稿时是否要求提供DSS，以及它们在已发表的试验报告中对所宣称要求的遵守情况。

方法

纳入《期刊引证报告》（JCR，截至2023年6月）定义的“内分泌与代谢”类别且在2019年至2022年期间发表临床试验报告的期刊进行分析。主要结局是一本期刊在其临床试验稿件提交说明中是否明确要求提供DSS，于2023年12月提取并核实。我们还评估了这些期刊在2023年12月至2024年5月期间发表的试验报告中是否确实包含DSS。

结果

共纳入141本内分泌与代谢领域的期刊进行分析，其中125本（88.7%）在临床试验投稿时要求提供DSS。与不要求提供DSS的期刊相比，要求提供DSS的期刊JCR四分位数显著更低，影响因子更高。在90本要求提供DSS的期刊中，有14本（15.6%）在2023年12月至2024年5月期间发表的试验报告中确实未发表任何DSS。