Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study.
Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study.
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DOI：
10.1136/bmj.i6770
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发表时间：
2017-01-17
期刊：
影响因子：
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通讯作者：
Keyhani S
中科院分区：
文献类型：
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作者：
Ahn R;Woodbridge A;Abraham A;Saba S;Korenstein D;Madden E;Boscardin WJ;Keyhani S
目的在考虑研究经费来源后，研究单个主要研究者与研究药物制造商的财务关系与试验结果之间的关系。设计随机对照试验（RCTs）的横断面研究。2013年1月1日至2013年12月31日在Medline确定的“核心临床”期刊上发表的研究。研究对象：关注药物疗效的随机对照试验。主要结果测量主要研究者的经济关系与研究结果之间的关系。结果共有190篇论文195项研究符合纳入标准。132项（67.7%）研究中存在主要研究者与制药行业之间的财务联系。在397名主要研究人员中，231名（58%）有经济关系，166名（42%）没有。在所有主要研究人员中，156人（39%）报告了顾问/咨询费用，81人（20%）报告了演讲费，81人（20%）报告了未指明的财务关系，52人（13%）报告了酬金，52人（13%）报告了员工关系，52人（13%）报告了差旅费，41人（10%）报告了股票所有权，20人（5%）报告了与研究药物相关的专利。在阳性研究中，主要研究者有经济关系的比例为76%(103/136)，在阴性研究中为49%（29/59）。在未经调整的分析中，经济关系的存在与积极的研究结果相关（优势比3.23,95%置信区间1.7至6.1）。在主要的多变量分析中，在调整研究资金来源后，财务相关性与阳性RCT结果显著相关（优势比3.57(1.7 - 7.7)）。二次分析控制了额外的RCT特征，如研究阶段、样本量、第一作者的国家、专业、试验注册、研究设计、分析类型、比较物和结果测量。这些特征没有明显影响经济关系和研究结果之间的关系（优势比3.37,1.4至7.9）。结论：主要研究者的经济关系与积极的临床试验结果独立相关。这些发现可能暗示了证据基础的偏差。
Objective To examine the association between the presence of individual principal investigators’ financial ties to the manufacturer of the study drug and the trial’s outcomes after accounting for source of research funding. Design Cross sectional study of randomized controlled trials (RCTs). Setting Studies published in “core clinical” journals, as identified by Medline, between 1 January 2013 and 31 December 2013. Participants Random sample of RCTs focused on drug efficacy. Main outcome measure Association between financial ties of principal investigators and study outcome. Results A total of 190 papers describing 195 studies met inclusion criteria. Financial ties between principal investigators and the pharmaceutical industry were present in 132 (67.7%) studies. Of 397 principal investigators, 231 (58%) had financial ties and 166 (42%) did not. Of all principal investigators, 156 (39%) reported advisor/consultancy payments, 81 (20%) reported speakers’ fees, 81 (20%) reported unspecified financial ties, 52 (13%) reported honorariums, 52 (13%) reported employee relationships, 52 (13%) reported travel fees, 41 (10%) reported stock ownership, and 20 (5%) reported having a patent related to the study drug. The prevalence of financial ties of principal investigators was 76% (103/136) among positive studies and 49% (29/59) among negative studies. In unadjusted analyses, the presence of a financial tie was associated with a positive study outcome (odds ratio 3.23, 95% confidence interval 1.7 to 6.1). In the primary multivariate analysis, a financial tie was significantly associated with positive RCT outcome after adjustment for the study funding source (odds ratio 3.57 (1.7 to 7.7). The secondary analysis controlled for additional RCT characteristics such as study phase, sample size, country of first authors, specialty, trial registration, study design, type of analysis, comparator, and outcome measure. These characteristics did not appreciably affect the relation between financial ties and study outcomes (odds ratio 3.37, 1.4 to 7.9). Conclusions Financial ties of principal investigators were independently associated with positive clinical trial results. These findings may be suggestive of bias in the evidence base.