Nejstgaard Camilla Hansen, Laursen David Ruben Teindl, Lundh Andreas, Hróbjartsson Asbjørn
Centre for Evidence-Based Medicine Odense (CEBMO) and Cochrane Denmark, Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
Open Patient Data Explorative Network (OPEN), Odense University Hospital, Odense, Denmark.
Res Synth Methods. 2023 Mar;14(2):144-155. doi: 10.1002/jrsm.1611. Epub 2022 Dec 2.
We investigated to which degree commercial funding is associated with estimated intervention effects in randomized trials. We included meta-epidemiological studies with published data on the association between commercial funding and results or conclusions of randomized trials. We searched five databases and other sources. We selected one result per meta-epidemiological study, preferably unadjusted ratio of odds ratios (ROR), for example, odds ratio(commercial funding)/odds ratio(noncommercial funding). We pooled RORs in random-effects meta-analyses (ROR <1 indicated exaggerated intervention effects in commercially funded trials), subgrouped (preplanned) by study aim: commercial funding per se versus risk of commercial funder influence. We included eight meta-epidemiological studies (264 meta-analyses, 2725 trials). The summary ROR was 0.95 (95% confidence interval 0.85-1.06). Subgroup analysis revealed a difference (p = 0.02) between studies of commercial funding per se, ROR 1.06 (0.95-1.17) and studies of risk of commercial funder influence, ROR 0.88 (0.79-0.97). In conclusion, we found no statistically significant association between commercial funding and estimated intervention effects when combining studies of commercial funding per se and studies of risk of commercial funder influence. A preplanned subgroup analysis indicated that trials with high risk of commercial funder influence exaggerated intervention effects by 12% (21%-3%), on average. Our results differ from previous theoretical considerations and findings from methodological studies and therefore call for confirmation. We suggest it is prudent to interpret results from commercially funded trials with caution, especially when there is a risk that the funder had direct influence on trial design, conduct, analysis, or reporting.
我们调查了商业资金与随机试验中估计的干预效果之间的关联程度。我们纳入了关于商业资金与随机试验结果或结论之间关联的已发表数据的元流行病学研究。我们检索了五个数据库及其他来源。我们为每项元流行病学研究选取一个结果,最好是未调整的比值比(ROR),例如,比值比(商业资金资助)/比值比(非商业资金资助)。我们在随机效应荟萃分析中汇总了比值比(ROR<1表明在商业资金资助的试验中干预效果被夸大),并按研究目的进行了(预先计划的)亚组分析:商业资金本身与商业资助者影响风险。我们纳入了八项元流行病学研究(264项荟萃分析,2725项试验)。汇总的比值比为0.95(95%置信区间0.85 - 1.06)。亚组分析显示,商业资金本身的研究(比值比1.06,0.95 - 1.17)与商业资助者影响风险的研究(比值比0.88,0.79 - 0.97)之间存在差异(p = 0.02)。总之,当将商业资金本身的研究与商业资助者影响风险的研究结合起来时,我们发现商业资金与估计的干预效果之间没有统计学上的显著关联。一项预先计划的亚组分析表明,商业资助者影响风险高的试验平均将干预效果夸大了12%(21% - 3%)。我们的结果与先前的理论考量以及方法学研究的结果不同,因此需要进一步证实。我们建议谨慎解读商业资金资助试验的结果,尤其是当资助者可能对试验设计、实施、分析或报告有直接影响时。