MediCC, Medical Communications Consultants, LLC, 103 Van Doren Place, Chapel Hill, NC 27517, USA.
J Med Ethics. 2011 Nov;37(11):688-92. doi: 10.1136/jme.2011.043133. Epub 2011 May 17.
Clinical papers so flawed that they are eventually retracted may put patients at risk. Patient risk could arise in a retracted primary study or in any secondary study that draws ideas or inspiration from a primary study.
To determine how many patients were put at risk, we evaluated 788 retracted English-language papers published from 2000 to 2010, describing new research with humans or freshly derived human material. These primary papers-together with all secondary studies citing them-were evaluated using ISI Web of Knowledge. Excluded from study were 468 basic science papers not studying fresh human material; 88 reviews presenting older data; 22 case reports; 7 papers retracted for journal error and 23 papers unavailable on Web of Knowledge. Overall, 180 retracted primary papers (22.8%) met the inclusion criteria. Subjects enrolled and patients treated in 180 primary studies and 851 secondary studies were combined.
Retracted papers were cited over 5000 times, with 93% of citations being research related, suggesting that ideas promulgated in retracted papers can influence subsequent research. Over 28 000 subjects were enrolled-and 9189 patients were treated-in 180 retracted primary studies. Over 400 000 subjects were enrolled-and 70 501 patients were treated-in 851 secondary studies which cited a retracted paper. Papers retracted for fraud (n=70) treated more patients per study (p<0.01) than papers retracted for error (n=110).
Many patients are put at risk by retracted studies. These are conservative estimates, as only patients enrolled in published clinical studies were tallied.
有缺陷而最终被撤回的临床论文可能使患者面临风险。这种风险可能来自被撤回的原始研究，也可能来自从原始研究中汲取创意或灵感的任何二次研究。
为了确定有多少患者面临风险，我们评估了 2000 年至 2010 年期间发表的 788 篇撤回的英文临床论文，这些论文描述了新的人体研究或利用新获取的人体材料开展的研究。这些原始论文以及所有引用它们的二次研究，都使用 ISI Web of Knowledge 进行了评估。研究排除了 468 篇不研究新鲜人体材料的基础科学论文、88 篇呈现旧数据的综述、22 篇病例报告、7 篇因期刊错误而被撤回的论文以及 23 篇无法在 Web of Knowledge 上获取的论文。总的来说，180 篇原始论文（22.8%）符合纳入标准。将 180 项原始研究和 851 项二次研究中纳入的受试者和接受治疗的患者合并在一起。
撤回的论文被引用了 5000 多次，其中 93%的引用与研究有关，这表明撤回论文中提出的观点可能会影响后续研究。在 180 项撤回的原始研究中，有超过 28000 名受试者入组，9189 名患者接受了治疗。在引用了撤回论文的 851 项二次研究中，有超过 400000 名受试者入组，70501 名患者接受了治疗。因欺诈而被撤回的论文（n=70）每篇研究治疗的患者数量多于因错误而被撤回的论文（n=110）（p<0.01）。
许多患者因撤回的研究而面临风险。这只是保守估计，因为只统计了发表的临床研究中纳入的患者。
