Influence and management of conflicts of interest in randomised clinical trials: qualitative interview study
Open accessAbstract
Objective: To characterise and analyse the experiences of trial researchers of if and how conflicts of interest had unduly influenced clinical trials they had worked on, what management strategies they had used to minimise any potential influence, and their experiences and views on conflicts of interest more generally. Design: Qualitative interview study. Participants: Trial researchers who had participated in at least 10 clinical trials with methodological or statistical expertise. Researchers differed by geographical location, educational background, and experience with different types of funders. Interviewees were identified by searches on Web of Science and snowball sampling. 52 trial researchers were approached by email; 20 agreed to be interviewed. Setting: Interviews conducted by telephone, recorded, transcribed verbatim, imported to NVivo 12, and analysed by systematic text condensation. Semistructured interviews focused on financial and non-financial conflicts of interest. Results: The interviewees had participated in a median of 37.5 trials and were mainly male physicians who had experience with commercial and non-commercial trial funders. Two predefined themes (influence of conflicts of interest and management strategies) and two additional themes (definition and reporting of conflicts of interest) emerged. Examples of perceived influence of conflicts of interest were: choice of inferior comparator, manipulation of the randomisation process, prematurely stopping the trials, fabrication of data, blocking access to data, and spin (eg, overly favourable interpretation of the results). Examples of strategies to manage conflicts of interest were: disclosure procedures, exclusion of the funder from design and analysis, independent committees, contracts ensuring complete access to the data, and no restriction by the funder on analysis and reporting. Interviewees used different definitions or thresholds for what they considered to be conflicts of interest, and they described different criteria for when to report them. Some interviewees considered non-commercial financial conflicts of interest (eg, funding of trials by governmental health agencies with a political agenda) to be equally or more important than commercial financial conflicts of interest (eg, funding by drug and device companies), but more challenging to report and manage. Conclusion: This study described how trial researchers perceive conflicts of interest unduly influencing clinical trials they had worked on, and the management strategies they used to prevent these influences. The results indicated considerable variability in researchers’ understanding of what conflicts of interest are and when they should be reported.
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Undue influence on trials from non-industry funders with a strong interest in a specific trial result has been described, although studied less.
“Undue influence on trials from non-industry funders with a strong interest in a specific trial result has been described,107 although studied less.”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [107]
Conflicts of interest are most often associated with drug and device industries, but may exist with support from or affiliation with government agencies, charities, and professional and civic organisations, although these associations have been much less investigated.
“Conflicts of interest are most often associated with drug and device industries, but they may exist with support from or affiliation with government agencies, charities (not-for-profit organisations), and professional and civic organisations,107 although these associations have been much less investigated.”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [107]
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- Authors
- Østengaard, L., Lundh, A., Tjørnhøj-Thomsen, T., Abdi, S., Gelle, M. H. A., Stewart, L. A., Boutron, I., & Hróbjartsson, A.
- Affiliations
- University of Southern Denmark (DK)
- Odense University Hospital (DK)
- University of York (GB)
- Inserm (FR)
- Corresponding author
- Østengaard, Lasse
- Venue
- BMJ
- Publisher
- BMJ
- Published
- 2020-10-27
- Volume
- 371
- Pages
- m3764
- ISSN
- 1756-1833 (ISSN-L)
- PMC
- PMC7590918
- OpenAlex
- W3097362881
- Cited by
- 35
- References
- 49
- Citations by year
- 2026: 7 · 2025: 6 · 2024: 6 · 2023: 8 · 2022: 4 · 2021: 4
- FWCI
- 3.54
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- BMJ (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- White Rose Research Online (University of Leeds, The University of Sheffield, University of York) (acceptedVersion)
- University of Southern Denmark Research Portal (University of Southern Denmark) (submittedVersion, cc-by-nc)
- HAL (submittedVersion)
- HighWire Press Open Archive (submittedVersion)
- Funders
- National Institute for Health and Care Research (NF-SI-0507-10259)
- 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 › Safety Research › Academic integrity and plagiarism
- Keywords
- conflicts of interest, randomized controlled trials, research integrity, conflict management strategies, conflict of interest disclosure, commercial funding, data access
- MeSH terms
- Female, Humans, Male, Research Personnel, Randomized Controlled Trials as Topic, Conflict of Interest, Qualitative Research
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