Ghost authorship in industry-initiated randomised trials.
Ghost authorship in industry-initiated randomised trials.
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DOI：
10.1371/journal.pmed.0040019
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发表时间：
2007-01
期刊：
影响因子：
15.8
通讯作者：
Chan AW
中科院分区：
文献类型：
--
作者：
Gøtzsche PC;Hróbjartsson A;Johansen HK;Haahr MT;Altman DG;Chan AW
“幽灵作者”，即没有指明对一篇文章做出重大贡献的个人的名字，可能会导致缺乏问责。在行业发起的随机试验中，幽灵作者的流行程度和性质尚不清楚。我们进行了一项队列研究，比较了1994-1995年哥本哈根和腓特烈斯堡科学伦理委员会批准的行业发起的试验的方案和相应的出版物。如果撰写试验方案、执行统计分析或撰写手稿的个人没有被列为出版物的作者、研究小组或写作委员会的成员或致谢，我们将幽灵作者定义为存在。我们确定了44项由行业发起的试验。我们没有发现任何试验方案或出版物明确声明临床研究报告或手稿由临床研究人员撰写或由临床研究人员撰写，也没有任何方案声明临床研究人员参与数据分析。我们在33个试验中发现了幽灵作者的证据（75%；95%置信区间为60%-87%）。当我们将符合作者资格的人被承认而不是以作者的身份出现的情况包括在内时，幽灵作者的发生率增加到91%（44篇文章中有40篇；95%置信区间为78%-98%）。在31项试验中，我们确定的“幽灵作者”是统计学家。我们很可能忽略了一些代笔作者，因为我们有非常有限的信息来确定可能遗漏的其他有资格作为作者的个人。在行业发起的试验中，幽灵作者是很常见的。如果现有的指导方针得到遵守，如果议定书能够公开，那么它的流行率可以大大降低，透明度可以提高。在44项由行业发起的试验中，有33项存在幽灵作者的证据，当符合作者资格的人被承认而不是以作者的身份出现时，这一数字增加到40项。原始的科学发现通常以“论文”的形式发表，无论是在纸上分发，还是通过互联网传播，就像这篇一样。论文通常是由一组研究人员编写的，他们做了这项研究，然后在文章的顶部列出。因此，这些作者对结果的完整性和解释负责。然而，许多人担心，有时论文上的作者名单并没有告诉谁参与了真实的故事。特别是在临床研究中，病例历史和以前的研究表明，“幽灵作者”是司空见惯的。幽灵作者是指那些以某种方式参与研究或撰写论文的人，但他们被排除在最终作者名单之外。这可能是因为如果不透露真正的作者（例如，公司员工或自由医学作家），研究“看起来”更可信。这种做法可能隐藏了读者应该意识到的竞争利益，因此受到了学者、编辑团体和一些制药公司的谴责。这组研究人员想知道，在公司进行的医学研究中，幽灵作者的情况有多频繁。之前的研究采用了调查的方式，研究人员会给一组论文的一位作者写信，询问是否还有其他人参与了这项工作，但没有在论文中列出。这类研究通常低估了“幽灵作者”的比例，因为主要作者可能不想承认发生了什么。然而，这里的研究人员设法获得了试验协议（制定未来研究计划的文件），这给了他们一种调查幽灵作者的方法。为了调查幽灵作者的频率和类型，这些研究人员确定了1994年至1995年间由哥本哈根和丹麦腓特烈斯堡伦理委员会批准的每一项试验。然后，他们将这个群体筛选出来，只包括由行业（制药公司和其他公司）赞助的试验，只包括那些已经完成并发表的试验。每个试验的方案都是从伦理委员会获得的，然后研究人员将每个方案与其相应的论文进行匹配。然后，他们将协议中出现的名字与最终论文中出现的名字进行比较，这些名字要么出现在作者名单上，要么在论文的其他地方被承认参与了研究。研究人员最终研究了44项试验。在其中的31份（75%）中，他们发现了一些幽灵作者的证据，因为这些人被确定为撰写了协议或参与了统计分析或撰写手稿，但最终没有出现在手稿中。如果作者身份的定义更窄，并且“幽灵作者身份”包括在致谢中提到但没有在作者名单中提到的有资格获得作者身份的人，研究人员的估计上升到91%，即44项试验中的40项。在大多数作者失踪的试验中，幽灵是一名统计学家（分析试验数据的人）。在这项研究中，研究人员发现，在医学期刊上发表的论文中，幽灵作者非常普遍（这项研究涵盖了许多医学学科的广泛同行评议期刊）。论文中使用的方法似乎比使用调查来计算幽灵作者发生的频率更可靠。研究人员的目标是使用一个名为国际医学期刊编辑委员会（ICMJE）的组织制定的政策来定义作者身份，这里的发现表明，ICMJE的作者标准经常被忽视。这意味着，阅读已发表论文的人不能总是准确地判断或信任其中呈现的信息，而且可能隐藏着相互竞争的利益。这里的研究人员建议，协议应该公开，这样每个人都能看到计划进行什么试验，以及谁参与了这些试验。研究结果还表明，期刊不仅应该列出每篇论文的作者，还应该描述每位作者所做的工作，这样发表的信息才能准确地反映出已经进行的研究。请通过本摘要的在线版本http://dx.doi.org/10.1371/journal.pmed.0040019访问这些网站。国际医学期刊编辑委员会（ICMJE）是一个由普通医学期刊编辑组成的团体，他们制定了生物医学手稿的一般准则；出版伦理委员会是一个论坛，供同行评议期刊的编辑讨论与科学记录完整性有关的问题；该网站列出了匿名问题和委员会的建议，不仅涉及作者身份，还包括其他类型的问题。《制药公司良好出版实践》概述了行业资助的医学研究发表的共同标准，一些制药公司已经同意这些标准
Ghost authorship, the failure to name, as an author, an individual who has made substantial contributions to an article, may result in lack of accountability. The prevalence and nature of ghost authorship in industry-initiated randomised trials is not known. We conducted a cohort study comparing protocols and corresponding publications for industry-initiated trials approved by the Scientific-Ethical Committees for Copenhagen and Frederiksberg in 1994–1995. We defined ghost authorship as present if individuals who wrote the trial protocol, performed the statistical analyses, or wrote the manuscript, were not listed as authors of the publication, or as members of a study group or writing committee, or in an acknowledgment. We identified 44 industry-initiated trials. We did not find any trial protocol or publication that stated explicitly that the clinical study report or the manuscript was to be written or was written by the clinical investigators, and none of the protocols stated that clinical investigators were to be involved with data analysis. We found evidence of ghost authorship for 33 trials (75%; 95% confidence interval 60%–87%). The prevalence of ghost authorship was increased to 91% (40 of 44 articles; 95% confidence interval 78%–98%) when we included cases where a person qualifying for authorship was acknowledged rather than appearing as an author. In 31 trials, the ghost authors we identified were statisticians. It is likely that we have overlooked some ghost authors, as we had very limited information to identify the possible omission of other individuals who would have qualified as authors. Ghost authorship in industry-initiated trials is very common. Its prevalence could be considerably reduced, and transparency improved, if existing guidelines were followed, and if protocols were publicly available. Of 44 industry-initiated trials, there was evidence of ghost authorship in 33, increasing to 40 when a person qualifying for authorship was acknowledged rather than appearing as an author. Original scientific findings are usually published in the form of a “paper”, whether it is actually distributed on paper, or circulated via the internet, as this one is. Papers are normally prepared by a group of researchers who did the research and are then listed at the top of the article. These authors therefore take responsibility for the integrity of the results and interpretation of them. However, many people are worried that sometimes the author list on the paper does not tell the true story of who was involved. In particular, for clinical research, case histories and previous research has suggested that “ghost authorship” is commonplace. Ghost authors are people who were involved in some way in the research study, or writing the paper, but who have been left off the final author list. This might happen because the study “looks” more credible if the true authors (for example, company employees or freelance medical writers) are not revealed. This practice might hide competing interests that readers should be aware of, and has therefore been condemned by academics, groups of editors, and some pharmaceutical companies. This group of researchers wanted to get an idea of how often ghost authorship happened in medical research done by companies. Previous studies looking into this used surveys, whereby the researchers would write to one author on each of a group of papers to ask whether anyone else had been involved in the work but who was not listed on the paper. These sorts of studies typically underestimate the rate of ghost authorship, because the main author might not want to admit what had been going on. However, the researchers here managed to get access to trial protocols (documents setting out the plans for future research studies), which gave them a way to investigate ghost authorship. In order to investigate the frequency and type of ghost authorship, these researchers identified every trial which was approved between 1994 and 1995 by the ethics committees of Copenhagen and Frederiksberg in Denmark. Then they winnowed this group down to include only the trials that were sponsored by industry (pharmaceutical companies and others), and only those trials that were finished and published. The protocols for each trial were obtained from the ethics committees and the researchers then matched up each protocol with its corresponding paper. Then, they compared names which appeared in the protocol against names appearing on the eventual paper, either on the author list or acknowledged elsewhere in the paper as being involved. The researchers ended up studying 44 trials. For 31 of these (75% of them) they found some evidence of ghost authorship, in that people were identified as having written the protocol or who had been involved in doing statistical analyses or writing the manuscript, but did not end up listed in the manuscript. If the definition of authorship was made narrower, and “ghost authorship” included people qualifying for authorship who were mentioned in the acknowledgements but not the author list, the researchers' estimate went up to 91%, that is 40 of the 44 trials. For most of the trials with missing authors, the ghost was a statistician (the person who analyzes the trial data). In this study, the researchers found that ghost authorship was very common in papers published in medical journals (this study covered a broad range of peer-reviewed journals in many medical disciplines). The method used in this paper seems more reliable than using surveys to work out how often ghost authorship happens. The researchers aimed to define authorship using the policies set out by a group called the International Committee of Medical Journal Editors (ICMJE), and the findings here suggest that the ICMJE's standards for authorship are very often ignored. This means that people who read the published paper cannot always accurately judge or trust the information presented within it, and competing interests may be hidden. The researchers here suggest that protocols should be made publicly available so that everyone can see what trials are planned and who is involved in conducting them. The findings also suggest that journals should not only list the authors of each paper but describe what each author has done, so that the published information accurately reflects what has been carried out. Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0040019. Read the Perspective by Liz Wager, which discusses these findings in more depth The International Committee of Medical Journal Editors (ICMJE) is a group of general medical journal editors who have produced general guidelines for biomedical manuscripts; their definition of authorship is also described The Committee on Publication Ethics is a forum for editors of peer-reviewed journals to discuss issues related to the integrity of the scientific record; the Web site lists anonymized problems and the committee's advice, not just regarding authorship, but other types of problems as well Good Publication Practice for Pharmaceutical Companies outlines common standards for publication of industry-sponsored medical research, and some pharmaceutical companies have agreed to these
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