Investigator experiences with financial conflicts of interest in clinical trials
Open accessAbstract
BACKGROUND: Financial conflicts of interest (fCOI) can introduce actions that bias clinical trial results and reduce their objectivity. We obtained information from investigators about adherence to practices that minimize the introduction of such bias in their clinical trials experience. METHODS: Email survey of clinical trial investigators from Canadian sites to learn about adherence to practices that help maintain research independence across all stages of trial preparation, conduct, and dissemination. The main outcome was the proportion of investigators that reported full adherence to preferred trial practices for all of their trials conducted from 2001-2006, stratified by funding source. RESULTS: 844 investigators responded (76%) and 732 (66%) provided useful information. Full adherence to preferred clinical trial practices was highest for institutional review of signed contracts and budgets (82% and 75% of investigators respectively). Lower rates of full adherence were reported for the other two practices in the trial preparation stage (avoidance of confidentiality clauses, 12%; trial registration after 2005, 39%). Lower rates of full adherence were reported for 7 practices in the trial conduct (35% to 43%) and dissemination (53% to 64%) stages, particularly in industry funded trials. 269 investigators personally experienced (n = 85) or witnessed (n = 236) a fCOI; over 70% of these situations related to industry trials. CONCLUSION: Full adherence to practices designed to promote the objectivity of research varied across trial stages and was low overall, particularly for industry funded trials.
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References 31 · Cited by 31
- Authors
- Rochon, P. A., Sekeres, M., Hoey, J., Lexchin, J., Ferris, L. E., Moher, D., Wu, W., Kalkar, S. R., Van Laethem, M., Gruneir, A., Gold, J., Maskalyk, J., Streiner, D. L., Taback, N., & Chan, A.-W.
- Affiliations
- Women's College Hospital (CA)
- University of Toronto (CA)
- University Health Network (CA)
- University of Ottawa (CA)
- Ontario Medical Association (CA)
- Corresponding author
- Rochon, Paula A
- ORCID
- Venue
- Trials
- Published
- 2011-01-12
- Volume
- 12
- Issue
- 1
- Pages
- 9-9
- ISSN
- 1745-6215 (ISSN-L)
- PMC
- PMC3031202
- OpenAlex
- W2154317807
- Cited by
- 31
- References
- 31
- Citations by year
- 2026: 1 · 2025: 1 · 2024: 1 · 2023: 3 · 2022: 1 · 2021: 3 · 2020: 4 · 2019: 1 · 2018: 1 · 2016: 2 · 2015: 1 · 2014: 1 · 2013: 5 · 2012: 4
- FWCI
- 4.05
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Trials (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- uO Research (University of Ottawa) (submittedVersion, public-domain)
- TSpace (University of Toronto) (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- DigitalGeorgetown (Georgetown University Library) (submittedVersion)
- Funders
- Canadian Institutes of Health Research (77338_1)
- 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
- financial conflicts of interest, clinical trial investigators, scientific objectivity, research autonomy, industry-funded trials, clinical trial registration, confidentiality clauses, research bias
- MeSH terms
- Canada, Clinical Trials as Topic, Confidentiality, Humans, Surveys and Questionnaires, Registries, Research Design, Research Support as Topic, Truth Disclosure, Reproducibility of Results, Bias, Conflict of Interest, Guidelines as Topic, Evidence-Based Medicine, Health Care Sector, Guideline Adherence, Electronic Mail
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