Association of funding and conclusions in randomized drug trials - A reflection of treatment effect or adverse events?
Association of funding and conclusions in randomized drug trials - A reflection of treatment effect or adverse events?
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DOI：
10.1001/jama.290.7.921
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发表时间：
2003-08-20
影响因子：
120.7
通讯作者：
Kjaergard, LL
中科院分区：
文献类型：
--
作者：
Als-Nielsen, B;Chen, WD;Kjaergard, LL
背景以往的研究表明，行业赞助的试验往往得出pro-industry conclusions.Objective探讨是否在随机药物试验的资金和结论之间的关联反映治疗效果或不良事件.Design Observational study of 370随机药物试验纳入荟萃分析从科克伦审查选择从科克伦图书馆，2001年5月。从167篇科克伦综述的随机样本中，25篇包含合格的荟萃分析（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）。每项荟萃分析的主要二元结局被视为每项荟萃分析中纳入的所有试验的主要结局。通过logistic回归分析研究资金和结论之间的关系，并调整治疗效果、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）。主要结果测量试验结论，分为是否推荐实验药物作为治疗选择。结果推荐实验药物作为治疗选择在16%由非营利组织资助的试验中，30%的试验没有报告资金，35%的试验由非营利组织和营利组织资助，51%的试验由营利组织资助（P
Context Previous studies indicate that industry-sponsored trials tend to draw pro-industry conclusions.Objective To explore whether the association between funding and conclusions in randomized drug trials reflects treatment effects or adverse events.Design 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).Main Outcome Measure Conclusions in trials, classified into whether the experimental drug was recommended as the treatment of choice or not.Results 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