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提高行业资助临床试验出版物贡献者披露透明度的五步作者框架。

Five-step authorship framework to improve transparency in disclosing contributors to industry-sponsored clinical trial publications.

作者信息

Marušić Ana, Hren Darko, Mansi Bernadette, Lineberry Neil, Bhattacharya Ananya, Garrity Maureen, Clark Juli, Gesell Thomas, Glasser Susan, Gonzalez John, Hustad Carolyn, Lannon Mary-Margaret, Mooney LaVerne A, Peña Teresa

机构信息

Department of Research in Biomedicine and Health, University of Split School of Medicine, Šoltanska 2, 21000, Split, Croatia.

University of Split School of Humanities and Social Sciences, Split, Croatia.

出版信息

BMC Med. 2014 Oct 24;12:197. doi: 10.1186/s12916-014-0197-z.

DOI:10.1186/s12916-014-0197-z
PMID:25604352
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4209055/
Abstract

Authorship guidelines have established criteria to guide author selection based on significance of contribution and helped to define associated responsibilities and accountabilities for the published findings. However, low awareness, variable interpretation, and inconsistent application of these guidelines can lead to confusion and a lack of transparency when recognizing those who merit authorship. This article describes a research project led by the Medical Publishing Insights and Practices (MPIP) Initiative to identify current challenges when determining authorship for industry-sponsored clinical trials and develop an improved approach to facilitate decision-making when recognizing authors from related publications. A total of 498 clinical investigators, journal editors, publication professionals and medical writers were surveyed to understand better how they would adjudicate challenging, real-world authorship case scenarios, determine the perceived frequency of each scenario and rate their confidence in the responses provided. Multiple rounds of discussions about these results with journal editors, clinical investigators and industry representatives led to the development of key recommendations intended to enhance transparency when determining authorship. These included forming a representative group to establish authorship criteria early in a trial, having all trial contributors agree to these criteria and documenting trial contributions to objectively determine who warrants an invitation to participate in the manuscript development process. The resulting Five-step Authorship Framework is designed to create a more standardized approach when determining authorship for clinical trial publications. Overall, these recommendations aim to facilitate more transparent authorship decisions and help readers better assess the credibility of results and perspectives of the authors for medical research more broadly. Please see related article: http://www.biomedcentral.com/1741-7015/12/214.

摘要

作者身份指南已经确立了基于贡献重要性来指导作者选择的标准,并有助于界定已发表研究结果的相关责任。然而,这些指南的低认知度、不同的解读以及不一致的应用,在确定值得列为作者的人员时可能会导致混乱和缺乏透明度。本文描述了一个由医学出版洞察与实践(MPIP)倡议牵头的研究项目,旨在确定在为行业资助的临床试验确定作者身份时当前面临的挑战,并制定一种改进方法,以便在认可相关出版物的作者时促进决策制定。总共对498名临床研究人员、期刊编辑、出版专业人员和医学撰写人员进行了调查,以更好地了解他们将如何评判具有挑战性的现实世界作者身份案例场景,确定每种场景的感知频率,并对所提供回复的信心进行评级。与期刊编辑、临床研究人员和行业代表就这些结果进行的多轮讨论,促成了旨在提高确定作者身份时透明度的关键建议的制定。这些建议包括组建一个代表性小组,在试验早期确立作者身份标准,让所有试验贡献者都同意这些标准,并记录试验贡献,以便客观地确定谁有资格受邀参与稿件撰写过程。由此产生的五步作者身份框架旨在为临床试验出版物确定作者身份时创建一种更标准化的方法。总体而言,这些建议旨在促进更透明的作者身份决策,并帮助读者更全面地更好评估医学研究结果的可信度以及作者的观点。请参阅相关文章:http://www.biomedcentral.com/1741-7015/12/214 。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2882/4209055/9dae4f911451/12916_2014_197_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2882/4209055/e1c6c082f30d/12916_2014_197_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2882/4209055/9dae4f911451/12916_2014_197_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2882/4209055/e1c6c082f30d/12916_2014_197_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2882/4209055/9dae4f911451/12916_2014_197_Fig2_HTML.jpg

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