2013 - 2015年随机对照试验中资金来源与效应大小的关联：一项横断面调查与荟萃分析
The association of funding source on effect size in randomized controlled trials: 2013-2015 - a cross-sectional survey and meta-analysis.
作者信息
Falk Delgado Alberto, Falk Delgado Anna
机构信息
Department of Surgical Sciences, Uppsala University Hospital, 75185, Uppsala, Sweden.
Uppsala University Hospital, Akademiska sjukhuset, 75185, Uppsala, Sweden.
出版信息
Trials. 2017 Mar 14;18(1):125. doi: 10.1186/s13063-017-1872-0.
BACKGROUND
Trials financed by for-profit organizations have been associated with favorable outcomes of new treatments, although the effect size of funding source impact on outcome is unknown. The aim of this study was to estimate the effect size for a favorable outcome in randomized controlled trials (RCTs), stratified by funding source, that have been published in general medical journals.
METHODS
Parallel-group RCTs published in The Lancet, New England Journal of Medicine, and JAMA between 2013 and 2015 were identified. RCTs with binary primary endpoints were included. The primary outcome was the OR of patients' having a favorable outcome in the intervention group compared with the control group. The OR of a favorable outcome in each trial was calculated by the number of positive events that occurred in the intervention and control groups. A meta-analytic technique with random effects model was used to calculate summary OR. Data were stratified by funding source as for-profit, mixed, and nonprofit. Prespecified sensitivity, subgroup, and metaregression analyses were performed.
RESULTS
Five hundred nine trials were included. The OR for a favorable outcome in for-profit-funded RCTs was 1.92 (95% CI 1.72-2.14), which was higher than mixed source-funded RCTs (OR 1.34, 95% CI 1.25-1.43) and nonprofit-funded RCTs (OR 1.32, 95% CI 1.26-1.39). The OR for a favorable outcome was higher for both clinical and surrogate endpoints in for-profit-funded trials than in RCTs with other funding sources. Excluding drug trials lowered the OR for a favorable outcome in for-profit-funded RCTs. The OR for a favorable surrogate outcome in drug trials was higher in for-profit-funded trials than in nonprofit-funded trials.
CONCLUSIONS
For-profit-funded RCTs have a higher OR for a favorable outcome than nonprofit- and mixed source-funded RCTs. This difference is associated mainly with the use of surrogate endpoints in for-profit-financed drug trials.
背景
由营利性组织资助的试验与新治疗方法的良好疗效相关，尽管资金来源对疗效的影响大小尚不清楚。本研究的目的是估计在综合医学期刊上发表的、按资金来源分层的随机对照试验（RCT）中良好疗效的效应大小。
方法
确定2013年至2015年间发表在《柳叶刀》《新英格兰医学杂志》和《美国医学会杂志》上的平行组RCT。纳入具有二元主要终点的RCT。主要结局是干预组患者与对照组相比获得良好疗效的比值比（OR）。每个试验中良好疗效的OR通过干预组和对照组中发生的阳性事件数量计算得出。采用随机效应模型的荟萃分析技术计算汇总OR。数据按资金来源分层为营利性、混合型和非营利性。进行了预先设定的敏感性、亚组和元回归分析。
结果
共纳入509项试验。营利性资助的RCT中良好疗效的OR为1.92（95%CI 1.72 - 2.14），高于混合型资助的RCT（OR 1.34，95%CI 1.25 - 1.43）和非营利性资助的RCT（OR 1.32，95%CI 1.26 - 1.39）。营利性资助试验中临床和替代终点的良好疗效OR均高于其他资金来源的RCT。排除药物试验降低了营利性资助RCT中良好疗效的OR。营利性资助试验中药物试验的替代良好结局OR高于非营利性资助试验。
结论
营利性资助的RCT比非营利性和混合型资助的RCT具有更高的良好疗效OR。这种差异主要与营利性资助的药物试验中替代终点的使用有关。
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