Als-Nielsen Bodil, Chen Wendong, Gluud Christian, Kjaergard Lise L
The Copenhagen Trial Unit, Center for Clinical Intervention Research, Copenhagen University Hospital, Copenhagen, Denmark.
JAMA. 2003 Aug 20;290(7):921-8. doi: 10.1001/jama.290.7.921.
Previous studies indicate that industry-sponsored trials tend to draw proindustry conclusions.
To explore whether the association between funding and conclusions in randomized drug trials reflects treatment effects or adverse events.
Observational study of 370 randomized drug trials included in meta-analyses from Cochrane reviews selected from the Cochrane Library, May 2001. From a random sample of 167 Cochrane reviews, 25 contained eligible meta-analyses (assessed a binary outcome; pooled at least 5 full-paper trials of which at least 1 reported adequate and 1 reported inadequate allocation concealment). The primary binary outcome from each meta-analysis was considered the primary outcome for all trials included in each meta-analysis. The association between funding and conclusions was analyzed by logistic regression with adjustment for treatment effect, adverse events, and additional confounding factors (methodological quality, control intervention, sample size, publication year, and place of publication).
Conclusions in trials, classified into whether the experimental drug was recommended as the treatment of choice or not.
The experimental drug was recommended as treatment of choice in 16% of trials funded by nonprofit organizations, 30% of trials not reporting funding, 35% of trials funded by both nonprofit and for-profit organizations, and 51% of trials funded by for-profit organizations (P<.001; chi2 test). Logistic regression analyses indicated that funding, treatment effect, and double blinding were the only significant predictors of conclusions. Adjusted analyses showed that trials funded by for-profit organizations were significantly more likely to recommend the experimental drug as treatment of choice (odds ratio, 5.3; 95% confidence interval, 2.0-14.4) compared with trials funded by nonprofit organizations. This association did not appear to reflect treatment effect or adverse events.
Conclusions in trials funded by for-profit organizations may be more positive due to biased interpretation of trial results. Readers should carefully evaluate whether conclusions in randomized trials are supported by data.
先前的研究表明，行业资助的试验往往会得出有利于行业的结论。
探讨随机药物试验中资金与结论之间的关联是反映了治疗效果还是不良事件。
对2001年5月从考克兰图书馆选取的考克兰系统评价纳入的370项随机药物试验进行观察性研究。从167项考克兰系统评价的随机样本中，25项包含符合条件的系统评价（评估二元结局；汇总至少5项全文试验，其中至少1项报告了充分的分配隐藏，1项报告了不充分的分配隐藏）。每项系统评价的主要二元结局被视为该系统评价中所有试验的主要结局。通过逻辑回归分析资金与结论之间的关联，并对治疗效果、不良事件和其他混杂因素（方法学质量、对照干预、样本量、发表年份和发表地点）进行调整。
试验中的结论，分为是否推荐试验药物作为首选治疗方法。
在由非营利组织资助的试验中，16%的试验推荐试验药物作为首选治疗方法；在未报告资金来源的试验中，这一比例为30%；在由非营利组织和营利组织共同资助的试验中，为35%；在由营利组织资助的试验中，为51%（P<0.001；卡方检验）。逻辑回归分析表明，资金、治疗效果和双盲是结论的唯一显著预测因素。调整分析显示，与由非营利组织资助的试验相比，由营利组织资助的试验显著更有可能推荐试验药物作为首选治疗方法（优势比，5.3；95%置信区间，2.0 - 14.4）。这种关联似乎并未反映治疗效果或不良事件。
由于对试验结果的偏倚解释，营利组织资助的试验中的结论可能更为积极。读者应仔细评估随机试验中的结论是否有数据支持。
