Constraints on Publication Rights in Industry-Initiated Clinical Trials
Abstract
Udgivelsesdato: 2006/4/12
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Restrictions on publication have been imposed by various groups, including industry sponsors.
“Restrictions on publication have been imposed by various groups, including industry sponsors.38 49 50”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [38]
Most industry initiated trials are controlled by the company sponsoring and funding the trial; this authority is often enforced by contractual agreements signed between the company and trial investigators.
“Most industry initiated trials are controlled by the company sponsoring and funding the trial; this authority is often enforced by contractual agreements signed between the company and trial investigators.38 48”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [38]
These restrictions are sometimes not fully described in the protocol but rather in separate publication agreements.
“These restrictions are sometimes not fully described in the protocol but rather in separate publication agreements.38 51”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [38]
Naming of authors can help to identify conflicts of interest and reduce ghost and gift authorship.
“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 [38]
A third of protocols for industry initiated randomised trials that received ethics approval in Denmark in 1994-95 stated that the sponsor had access to accumulating trial data, which can introduce potential bias due to conflicts of interests.
“A third of protocols for industry initiated randomised trials that received ethics approval in Denmark in 1994-95 stated that the sponsor had access to accumulating trial data, which can introduce potential bias due to conflicts of interests.38”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [38]
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- Authors
- Gøtzsche, P. C., Hróbjartsson, A., Johansen, H. K., Haahr, M. T., Altman, D. G., & Chan, A.-W.
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2006-04-12
- Volume
- 295
- Issue
- 14
- Pages
- 1641
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- OpenAlex
- W2042264269
- Cited by
- 81
- References
- 5
- Citations by year
- 2026: 2 · 2025: 2 · 2022: 3 · 2021: 4 · 2020: 4 · 2019: 3 · 2018: 3 · 2016: 2 · 2015: 5 · 2014: 6 · 2013: 3 · 2012: 7
- FWCI
- 6.34
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- JAMA (publishedVersion)
- PubMed (publishedVersion)
- Research at the University of Copenhagen (University of Copenhagen) (submittedVersion)
- DigitalGeorgetown (Georgetown University Library) (submittedVersion)
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Social Sciences › Decision Sciences › Information Systems and Management › Academic Publishing and Open Access
- Keywords
- publication rights, industry-sponsored trials, conflicts of interest, clinical trial reporting, pharmaceutical industry
- MeSH terms
- Clinical Trials as Topic, Industry, Publishing, Research Support as Topic, Clinical Trials Data Monitoring Committees, Editorial Policies
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