Access to data in industry-sponsored trials
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For some trials, especially those sponsored by industry, access to the final trial dataset is restricted to the sponsor, which can introduce concerns about potential conflicts of interest.
“For some trials, especially those sponsored by industry, access to the final trial dataset is restricted to the sponsor, which can introduce concerns about potential conflicts of interest (item 3c).99”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [99]
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Cites
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SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials
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“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-citationSPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials
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Self-citationSPIRIT 2013: new guidance for content of clinical trial protocols
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SPIRIT 2013 Statement: defining standard protocol items for clinical trials.
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Self-citationSPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials
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Self-citationSponsors’ participation in conduct and reporting of industry trials: a descriptive study
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“However, this may not prevent sponsor influence, as academic authors often have constraints on publication rights [8,9], the sponsor often owns the data [9,10], ghost authorship is common [11], and academic authors may have industry ties [12].”
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“Concerns about the meaning of “access to data” and similar proposals to these have been discussed by a number of scholars [30–33].”
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SPIRIT 2013 Bildirisi: Klinik Deneyler İçin Standart Protokol Maddelerinin Tanımlanması
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Redactions in protocols for drug trials: what industry sponsors concealed
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Evaluation of Informed Consent Documents used in Critical Care Trials
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SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials
Akın, B., & Koçoğlu, D. (2020) · DergiPark (Istanbul University)
Addressing Conflicts of Interest in Clinical Trials
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Self-citation
- Authors
- Lundh, A., Krogsbøll, L. T., & Gøtzsche, P. C.
- Affiliations
- University of Copenhagen (DK)
- Rigshospitalet (DK)
- Corresponding author
- Lundh, Andreas
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2011-12
- Volume
- 378
- Issue
- 9808
- Pages
- 1995-1996
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W2070446707
- Cited by
- 28
- References
- 4
- Citations by year
- 2026: 1 · 2025: 1 · 2021: 4 · 2020: 3 · 2019: 2 · 2018: 2 · 2016: 3 · 2015: 2 · 2014: 2 · 2013: 5 · 2012: 3
- FWCI
- 3.39
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- The Lancet (publishedVersion)
- PubMed (publishedVersion)
- Research at the University of Copenhagen (University of Copenhagen) (submittedVersion)
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
- Physical Sciences › Computer Science › Information Systems › Research Data Management Practices
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Keywords
- industry-sponsored trials, data access, data sharing, research transparency, data ownership, publication rights, clinical research data
- MeSH terms
- Drug Industry, Humans, Periodicals as Topic, Surveys and Questionnaires, Research Support as Topic, Randomized Controlled Trials as Topic, Access to Information
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