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临床试验会议摘要与后续发表之间利益冲突财务披露不一致。

Discordant financial conflicts of interest disclosures between clinical trial conference abstract and subsequent publication.

作者信息

Weiss Glen J, Davis Roger B

机构信息

Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA.

Department of Medicine, Harvard Medical School, Boston, MA, USA.

出版信息

PeerJ. 2019 Feb 11;7:e6423. doi: 10.7717/peerj.6423. eCollection 2019.

Abstract

BACKGROUND

Financial conflicts of interest (FCOI) are known to be prevalent in medicine. Authorship of pivotal trials reap non-financial benefits including publication productivity that can be used for assessment of tenure positions and promotion. The purpose of this investigation was to quantify the prevalence and discordance of academic trial author (authors) FCOI in industry-sponsored drug trials that were initially presented as oral abstracts and subsequently resulted in a peer-reviewed publication.

METHODS

Oral abstracts from the American Society of Clinical Oncology (ASCO) 2017 Annual Meeting that were subsequently published were identified. Studies that were non-industry sponsored, non-adult, or non-therapeutic trials were excluded. Studies that did not have a subsequent peer-reviewed publication or had a publication preceding the ASCO 2017 Annual Meeting were also excluded. FCOI was categorized and impact factor (IF) for the journal at the time of publication was retrieved. FCOI discordance between the oral abstract and publication was calculated based on geographic location and IF.

RESULTS

A total of 22 paired abstract and publications met inclusion criteria for further analysis. A total of 384 authors were identified, of these 280 authors (74.1%) were included in both the oral abstract and subsequent publication. A total of 76% of these 280 authors had FCOI and 66.4% had FCOI discordance. There were statistically significant differences for the sum of FCOI discordance for U.S.-based authors ( = 0.0004) but not for journal IF. When analyzing the sum of absolute differences of FCOI discordance, statistical significance was reached for authors from any of the three geographic regions, as well as, low and high IF journals (all -values < 0.0001).

CONCLUSIONS

This study draws attention to the lack of uniformity and vetting of FCOI reporting in abstracts and journals publishing solid tumor oncology trial results. This is particularly concerning, since FCOI is prevalent globally.

摘要

背景

众所周知,经济利益冲突(FCOI)在医学领域普遍存在。关键试验的作者可获得非经济利益,包括可用于评估任期职位和晋升的发表成果。本研究的目的是量化在最初以口头摘要形式呈现、随后发表在同行评审期刊上的行业赞助药物试验中,学术试验作者的FCOI发生率及不一致性。

方法

识别出美国临床肿瘤学会(ASCO)2017年年会的口头摘要,这些摘要随后发表。排除非行业赞助、非成人或非治疗性试验的研究。未随后发表在同行评审期刊上或在ASCO 2017年年会之前已发表的研究也被排除。对FCOI进行分类,并检索发表时期刊的影响因子(IF)。根据地理位置和IF计算口头摘要与发表文章之间的FCOI不一致性。

结果

共有22对摘要和发表文章符合进一步分析的纳入标准。共识别出384位作者,其中280位作者(74.1%)同时出现在口头摘要和随后的发表文章中。这280位作者中,共有76%存在FCOI,66.4%存在FCOI不一致性。美国作者的FCOI不一致性总和存在统计学显著差异(P = 0.0004),但期刊IF不存在差异。在分析FCOI不一致性的绝对差异总和时,三个地理区域中任何一个区域的作者以及低IF和高IF期刊的作者均达到统计学显著性(所有P值<0.0001)。

结论

本研究提请注意在发表实体肿瘤肿瘤学试验结果的摘要和期刊中,FCOI报告缺乏一致性和审核。鉴于FCOI在全球普遍存在,这尤其令人担忧。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d5c9/6375255/69c89d4aa1ff/peerj-07-6423-g001.jpg

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