The DOI matches its Crossref record; 20 of the 20 references it cites were found in a registry or an index.
Ghost Authorship in Industry-Initiated Randomised Trials
Open accessAbstract
BACKGROUND: 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. METHODS AND FINDINGS: 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. CONCLUSIONS: 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.
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“Naming of authors can also help to identify conflicts of interest (item 7b) and reduce ghost and gift authorship.38 39 40 41”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [39]
In the citing paper
“Only a minority of reviews (2%) reported being funded by for-profit sources, but the true proportion may be higher [171].”
From The PRISMA Statement for Reporting Systematic Reviews and Meta-Analyses of Studies That Evaluate Health Care Interventions: Explanation and Elaboration (2009) · cites this paper as [171]
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Cites
Chan, A.-W., Hróbjartsson, A., Haahr, M. T., Gøtzsche, P. C., & Altman, D. G. (2004) · JAMA · doi:10.1001/jama.291.20.2457 · Cited by 1,845 · cited 1×
“For all published industry-initiated randomised trials approved in 1994–1995 by the Scientific-Ethical Committees for Copenhagen and Frederiksberg in Denmark, we compared the full trial protocols with the publications. We initially identified 274 approved trial protocols, but after extensive literature searches in MED…”
Self-citationUneasy alliance—clinical investigators and the pharmaceutical industry
Bodenheimer, T. (2000) · New England Journal of Medicine · doi:10.1056/nejm200005183422024 · Cited by 765 · cited 2×
“We conclude that ghost authorship in industry-initiated randomised trials is very common, and we believe that this practice serves commercial purposes [13,17,21,22].”
Als-Nielsen, B., Chen, W., Gluud, C., & Kjaergard, L. L. (2003) · JAMA · doi:10.1001/jama.290.7.921 · Cited by 746 · cited 1×
“We conclude that ghost authorship in industry-initiated randomised trials is very common, and we believe that this practice serves commercial purposes [13,17,21,22].”
Rennie, D. (1997) · JAMA · doi:10.1001/jama.278.7.579 · Cited by 685
Prevalence of Articles With Honorary Authors and Ghost Authors in Peer-Reviewed Medical Journals
Flanagin, A. (1998) · JAMA · doi:10.1001/jama.280.3.222 · Cited by 553 · cited 1×
“Authorship establishes accountability, responsibility, and credit for scientific articles [”
Narrative Review: The Promotion of Gabapentin: An Analysis of Internal Industry Documents
Steinman, M. A., Bero, L. A., Chren, M., & Landefeld, C. S. (2006) · Annals of Internal Medicine · doi:10.7326/0003-4819-145-4-200608150-00008 · Cited by 341 · cited 2×
“We conclude that ghost authorship in industry-initiated randomised trials is very common, and we believe that this practice serves commercial purposes [13,17,21,22].”
Krleža-Jerić, K., Chan, A., Dickersin, K., Sim, I., Grimshaw, J., & Gluud, C. N. (2005) · BMJ · doi:10.1136/bmj.330.7497.956 · Cited by 238
Self-citationPrevalence of Honorary and Ghost Authorship in Cochrane Reviews
Mowatt, G. (2002) · JAMA · doi:10.1001/jama.287.21.2769 · Cited by 229 · cited 4×
“In contrast, these two surveys, which relied on self-reporting, found rates of ghost authorship of 13% [1] and 11% [6], respectively.”
InfluentialInterface between authorship, industry and science in the domain of therapeutics
Healy, D., & Cattell, D. (2003) · The British Journal of Psychiatry · doi:10.1192/bjp.183.1.22 · Cited by 218 · cited 4×
“We conclude that ghost authorship in industry-initiated randomised trials is very common, and we believe that this practice serves commercial purposes [13,17,21,22].”
InfluentialGood publication practice for pharmaceutical companies
Wager, E., Field, E. A., & Grossman, L. (2003) · Current Medical Research and Opinion · doi:10.1185/030079903125001767 · Cited by 148
How Statistical Expertise Is Used in Medical Research
Altman, D. G. (2002) · JAMA · doi:10.1001/jama.287.21.2817 · Cited by 127 · cited 1×
“These findings are in sharp contrast to a survey, with a 75% response rate, of 704 authors of manuscripts submitted to the BMJ and the Annals of Internal Medicine (only a minority of which were randomised trials), which found that statisticians and similar methodologists who had made a significant contribution at some…”
Self-citationJacobs, A., & Wager, E. (2005) · Current Medical Research and Opinion · doi:10.1185/030079905x25578 · Cited by 124
Constraints on Publication Rights in Industry-Initiated Clinical Trials
Gøtzsche, P. C., Hróbjartsson, A., Johansen, H. K., Haahr, M. T., Altman, D. G., & Chan, A.-W. (2006) · JAMA · doi:10.1001/jama.295.14.1645 · Cited by 81
Self-citationHaunted Manuscripts: Ghost Authorship in the Medical Literature
Ngai, S., Gold, J., Gill, S. S., & Rochon, P. A. (2005) · Accountability in Research · doi:10.1080/08989620590957175 · Cited by 75 · cited 2×
“First, legal proceedings and testimonies suggest that it is very common for professional medical writers to compose trial reports, reviews, and other papers for the pharmaceutical industry, but that their role is not revealed [13–18].”
Ghost writing initiated by commercial companies
Fletcher, R. H. (2005) · Journal of General Internal Medicine · doi:10.1111/j.1525-1497.2005.41015.x · Cited by 46
Brennan, T. A. (1994) · New England Journal of Medicine · doi:10.1056/nejm199409083311012 · Cited by 34
Declaration of Medical Writing Assistance in International Peer-Reviewed Publications
Woolley, K. L., Ely, J. A., Woolley, M. J., Findlay, L., Lynch, F. A., Choi, Y., & McDonald, J. M. (2006) · JAMA · doi:10.1001/jama.296.8.932-b · Cited by 23 · cited 1×
“]. We found no references to medical writers in the protocols we reviewed, and they were acknowledged in only four publications (9%), which is consistent with a recent review of research articles [”
[Constraints on publication rights in industry-initiated clinical trials--secondary publication].
Gøtzsche, P. C., Hróbjartsson, A., Johansen, H. K., Haahr, M. T., Altman, D. G., & Chan, A. (2006) · PubMed · Cited by 13
Self-citationAuthorship of drug industry trials
Senn, S. J. (2002) · Pharmaceutical Statistics · doi:10.1002/pst.11 · Cited by 8 · cited 2×
“Omission of a company statistician, usually also from the acknowledgment section, deprives readers of a key insight into the role of the company, although it is sometimes evident that reports of industry-sponsored trials contain sophisticated statistical analyses that are beyond the capabilities of the authors [8].”
Wager, E. (1996) · BMJ · doi:10.1136/bmj.312.7043.1423b · Cited by 7
Research works printed but not linked: 20
- Flanagin, 1998, JAMA, 280, 222
- Gøtzsche, 2006, JAMA, 295, 1645
- Chan, 2004, JAMA, 291, 2457
- Mowatt, 2002, JAMA, 287, 2769
- Altman, 2002, JAMA, 287, 2817
- Senn, 2002, Pharmaceut Stat, 1, 5
- Wager, 1996, BMJ, 312, 1423
- Wager, 2003, Curr Med Res Opin, 19, 149
- Jacobs, 2005, Curr Med Res Opin, 21, 317
- Healy, 2003, Br J Psychiatry, 183, 22
- Barnett, 2003, The Guardian
- Gøtzsche, 2005, BMJ
- Steinman, 2006, Ann Intern Med, 145, 284
- Rees, 2003, BMJ
- Woolley, 2006, JAMA, 296, 932
- Bodenheimer, 2000, N Engl J Med, 342, 1539
- Als-Nielsen, 2003, JAMA, 290, 921
- Wager, 2003, Curr Med Res Opin, 19, 149
- Rennie, 1997, JAMA, 278, 579
- Krleza-Jerić, 2005, BMJ, 330, 956
Cited by
Sorted by citations
Liberati, A., Altman, D. G., Tetzlaff, J., Mulrow, C., Gøtzsche, P. C., Ioannidis, J. P. A., Clarke, M., Devereaux, P. J., Kleijnen, J., & Moher, D. (2009) · PLoS Medicine · doi:10.1371/journal.pmed.1000100 · Cited by 28,164
Self-citationLiberati, A., Altman, D. G., Tetzlaff, J., Mulrow, C., Gotzsche, P. C., Ioannidis, J. P. A., Clarke, M., Devereaux, P. J., Kleijnen, J., & Moher, D. (2009) · BMJ · doi:10.1136/bmj.b2700 · Cited by 17,648
Self-citationLiberati, A., Altman, D. G., Tetzlaff, J., Mulrow, C., Gøtzsche, P. C., Ioannidis, J. P. A., Clarke, M., Devereaux, P. J., Kleijnen, J., & Moher, D. (2009) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2009.06.006 · Cited by 10,578
Self-citationLiberati, A., Altman, D. G., Tetzlaff, J., Mulrow, C., Gøtzsche, P. C., Ioannidis, J. P. A., Clarke, M., Devereaux, P. J., Kleijnen, J., & Moher, D. (2009) · Annals of Internal Medicine · doi:10.7326/0003-4819-151-4-200908180-00136 · Cited by 10,349
“Only a minority of reviews (2%) reported being funded by for-profit sources, but the true proportion may be higher (171).”
BackgroundSelf-citationSPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials
Chan, A.-W., Tetzlaff, J. M., Altman, D. G., Laupacis, A., Gøtzsche, P. C., Krleža-Jerić, K., Hróbjartsson, A., Mann, H., Dickersin, K., Berlin, J. A., et al. (2013) · Annals of Internal Medicine · doi:10.7326/0003-4819-158-3-201302050-00583 · Cited by 7,363
“Many protocols for randomized trials do not adequately describe the primary outcomes (inadequate for 25% of trials) (18, 19), treatment allocation methods (inadequate for 54% to 79%) (20, 21), use of blinding (inadequate for 9% to 34%) (21, 22), methods for reporting adverse events (inadequate for 41%) (23), component…”
BackgroundSelf-citation
Metadata
- Authors
- Gøtzsche, P. C., Hróbjartsson, A., Johansen, H. K., Haahr, M. T., Altman, D. G., & Chan, A.-W.
- Affiliations
- Cochrane (DK)
- University of Oxford (GB)
- University of Toronto (CA)
- Corresponding author
- Gøtzsche, Peter C
- Venue
- PLoS Medicine
- Publisher
- Public Library of Science (PLoS)
- Published
- 2007-01-16
- Volume
- 4
- Issue
- 1
- Pages
- e19
- ISSN
- 1549-1277 (ISSN-L)
- 1549-1676
- PMC
- PMC1769411
- OpenAlex
- W2095312096
- Cited by
- 289
- References
- 20
- Citations by year
- 2026: 7 · 2025: 15 · 2024: 5 · 2023: 11 · 2022: 8 · 2021: 9 · 2020: 12 · 2019: 19 · 2018: 20 · 2017: 7 · 2016: 19 · 2015: 14 · 2014: 14 · 2013: 19 · 2012: 9
- FWCI
- 25.09
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- PLoS Medicine (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- RePEc: Research Papers in Economics (acceptedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- DigitalGeorgetown (Georgetown University Library) (submittedVersion)
- Funders
- Cancer Research UK
- Topics
- Health Sciences › Nursing › Issues, ethics and legal aspects › Pharmaceutical industry and healthcare
- Social Sciences › Education › Academic integrity and plagiarism
- Social Sciences › Library and Information Sciences › Academic Publishing and Open Access
- Keywords
- ghost authorship, authorship criteria, pharmaceutical industry, acknowledgment of contributors, research transparency
- MeSH terms
- Authorship, Humans, Publishing, Scientific Misconduct, Randomized Controlled Trials as Topic, Biomedical Research
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