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作者自述的利益冲突、试验赞助以及肿瘤学社论和相关 III 期试验的解释。

Self-reported conflicts of interest of authors, trial sponsorship, and the interpretation of editorials and related phase III trials in oncology.

机构信息

Instituto do Câncer do Estado de São Paulo, São Paulo, Brazil.

出版信息

J Clin Oncol. 2013 Jun 20;31(18):2289-95. doi: 10.1200/JCO.2012.46.6706. Epub 2013 Apr 29.

Abstract

PURPOSE

Growing participation by industry in cancer research has resulted in increased reporting of conflicts of interest (COI). We aimed to test any association between authors' conclusions and self-reported COI or trial sponsorship in cancer studies.

METHODS

Editorials and related phase III trials published in six clinical oncology journals in the last 3.5 years were analyzed independently by two investigators who classified study conclusions according to authors' endorsement of the experimental therapy. Logistic regression multivariable models were used to assess predictors of favorable conclusions of editorialists and of phase III authors.

RESULTS

From January 2008 to October 2011, 1,485 articles were retrieved: 150 phase III trials and 150 editorials were eligible. Among the phase III trials, 82 (54.7%) had positive results, and 78 (52.0%) were entirely or partially funded by industry. Any COI were disclosed in 103 phase III trials (68.7%) and in 71 editorials (47.3%). Multivariable analysis showed that phase III trial results were the only significant predictor for a positive conclusion by trial authors (odds ratio [OR], 92.2; 95% CI, 19.7 to 431.6; P < .001). Sponsorship did not predict for positive conclusion by phase III authors (OR, 0.86; 95% CI, 0.3 to 2.5; P = .788). The only factor associated with positive conclusions by editorial authors was a positive conclusion by phase III trial authors (OR, 36.3; 95% CI, 6.8 to 194.2; P < .001).

CONCLUSION

The interpretation of recently published phase III cancer trials by their authors or by editorialists was not influenced by financial relationships or industry sponsorship. Increased awareness of COI policies may have led to more integrity in cancer research reporting.

摘要

目的

由于工业界越来越多地参与癌症研究,导致越来越多的利益冲突(COI)报告。我们旨在检验作者的结论与自我报告的 COI 或癌症研究试验赞助之间是否存在任何关联。

方法

对过去 3.5 年中六本临床肿瘤学杂志上发表的社论和相关 III 期试验进行了两位研究者的独立分析,他们根据作者对实验疗法的认可对研究结论进行了分类。使用逻辑回归多变量模型来评估社论家和 III 期作者的有利结论的预测因素。

结果

从 2008 年 1 月至 2011 年 10 月,共检索到 1485 篇文章:150 项 III 期试验和 150 篇社论符合入选标准。在 III 期试验中,82 项(54.7%)有阳性结果,78 项(52.0%)完全或部分由工业界资助。在 103 项 III 期试验(68.7%)和 71 篇社论(47.3%)中披露了任何 COI。多变量分析显示,III 期试验结果是试验作者得出阳性结论的唯一显著预测因素(比值比[OR],92.2;95%CI,19.7 至 431.6;P <.001)。赞助并没有预测 III 期作者得出阳性结论(OR,0.86;95%CI,0.3 至 2.5;P =.788)。唯一与社论作者得出阳性结论相关的因素是 III 期试验作者得出阳性结论(OR,36.3;95%CI,6.8 至 194.2;P <.001)。

结论

作者或社论作者对最近发表的 III 期癌症试验的解释不受财务关系或工业赞助的影响。对 COI 政策的认识提高可能导致癌症研究报告更具完整性。

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