Abstract
BackgroundGhost 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.Methods and FindingsWe 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.ConclusionsGhost 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.
Highlights
Authorship establishes accountability, responsibility, and credit for scientific articles [1]
We examined directly the prevalence and nature of ghost authorship in a cohort of industry-initiated randomised trials by comparing the trial protocols with subsequent publications
We found evidence of ghost authorship for 31 of the 44 trials (75%; 95% confidence interval 60%–87%) (Table 1)
Summary
Authorship establishes accountability, responsibility, and credit for scientific articles [1]. One type of misappropriation is ghost authorship, which has been defined as the failure to name, as an author, an individual who has made substantial contributions to the research or writing of the article [1]. Papers are normally prepared by a group of researchers who did the research and are listed at the top of the article These authors take responsibility for the integrity of the results and interpretation of them. 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 been condemned by academics, groups of editors, and some pharmaceutical companies
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