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报告药物治疗试验荟萃分析中的利益冲突。

Reporting of conflicts of interest in meta-analyses of trials of pharmacological treatments.

机构信息

Department of Psychiatry, McGill University, Montréal, Québec, Canada.

出版信息

JAMA. 2011 Mar 9;305(10):1008-17. doi: 10.1001/jama.2011.257.

DOI:10.1001/jama.2011.257
PMID:21386079
Abstract

CONTEXT

Disclosure of conflicts of interest (COIs) from pharmaceutical industry study funding and author-industry financial relationships is sometimes recommended for randomized controlled trials (RCTs) published in biomedical journals. Authors of meta-analyses, however, are not required to report COIs disclosed in original reports of included RCTs.

OBJECTIVE

To investigate whether meta-analyses of pharmacological treatments published in high-impact biomedical journals report COIs disclosed in included RCTs.

DATA SOURCES AND STUDY SELECTION

We selected the 3 most recent meta-analyses of patented pharmacological treatments published January 2009 through October 2009 in each general medicine journal with an impact factor of at least 10; in high-impact journals in each of the 5 specialty medicine areas with the greatest 2008 global therapeutic sales (oncology, cardiology, respiratory medicine, endocrinology, and gastroenterology); and in the Cochrane Database of Systematic Reviews.

DATA EXTRACTION

Two investigators independently extracted data on disclosed study funding, author-industry financial ties, and author employment from each meta-analysis, from RCTs included in each meta-analysis, and on whether meta-analyses reported disclosed COIs of included RCTs.

RESULTS

Of 29 meta-analyses reviewed, which included 509 RCTs, only 2 meta-analyses (7%) reported RCT funding sources; and 0 reported RCT author-industry ties or employment by the pharmaceutical industry. Of 318 meta-analyzed RCTs that reported funding sources, 219 (69%) were industry funded; and 91 of 132 (69%) that reported author financial disclosures had 1 or more authors with pharmaceutical industry financial ties. In 7 of the 29 meta-analyses reviewed, 100% of included RCTs had at least 1 form of disclosed COI (pharmaceutical industry funding, author-industry financial ties, or employment), yet only 1 of these 7 meta-analyses reported RCT funding sources, and 0 reported RCT author-industry ties or employment.

CONCLUSION

Among a group of meta-analyses of pharmacological treatments published in high-impact biomedical journals, information concerning primary study funding and author COIs for the included RCTs were only rarely reported.

摘要

背景

有时建议在生物医学期刊上发表的随机对照试验(RCT)披露来自制药行业研究资助的利益冲突(COI)和作者与行业的财务关系。然而,荟萃分析的作者不需要报告纳入的 RCT 原始报告中披露的 COI。

目的

调查发表在高影响力生物医学期刊上的药物治疗荟萃分析是否报告了纳入的 RCT 中披露的 COI。

数据来源和研究选择

我们选择了每个具有至少 10 分影响因子的一般医学期刊在 2009 年 1 月至 2009 年 10 月发表的最新的 3 项专利药物治疗荟萃分析;在每个治疗销售额最大的 5 个专业医学领域的高影响力期刊中(肿瘤学、心脏病学、呼吸医学、内分泌学和胃肠病学);以及在 Cochrane 系统评价数据库中。

数据提取

两名调查员独立从每项荟萃分析中提取关于披露的研究资助、作者与行业的财务联系以及作者在制药行业的就业情况的数据,从每项荟萃分析中纳入的 RCT 中提取数据,以及关于荟萃分析是否报告了纳入 RCT 的披露 COI。

结果

在所审查的 29 项荟萃分析中,其中包括 509 项 RCT,只有 2 项荟萃分析(7%)报告了 RCT 资助来源;并且没有报告 RCT 作者与行业的联系或制药行业的就业情况。在报告资助来源的 318 项荟萃分析 RCT 中,219 项(69%)为行业资助;在报告作者财务披露的 132 项中的 91 项(69%)中,有 1 项或多项作者与制药行业有财务联系。在所审查的 29 项荟萃分析中,有 7 项的 100%纳入 RCT 至少有 1 种披露的 COI(制药行业资助、作者与行业的财务联系或就业),但这 7 项荟萃分析中只有 1 项报告了 RCT 资助来源,0 项报告了 RCT 作者与行业的联系或就业。

结论

在一组发表在高影响力生物医学期刊上的药物治疗荟萃分析中,关于纳入 RCT 的主要研究资助和作者 COI 的信息很少被报道。

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