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Pharmaceutical industry sponsorship and research outcome and quality: systematic review
Open accessAbstract
OBJECTIVE: To investigate whether funding of drug studies by the pharmaceutical industry is associated with outcomes that are favourable to the funder and whether the methods of trials funded by pharmaceutical companies differ from the methods in trials with other sources of support. METHODS: Medline (January 1966 to December 2002) and Embase (January 1980 to December 2002) searches were supplemented with material identified in the references and in the authors' personal files. Data were independently abstracted by three of the authors and disagreements were resolved by consensus. RESULTS: 30 studies were included. Research funded by drug companies was less likely to be published than research funded by other sources. Studies sponsored by pharmaceutical companies were more likely to have outcomes favouring the sponsor than were studies with other sponsors (odds ratio 4.05; 95% confidence interval 2.98 to 5.51; 18 comparisons). None of the 13 studies that analysed methods reported that studies funded by industry was of poorer quality. CONCLUSION: Systematic bias favours products which are made by the company funding the research. Explanations include the selection of an inappropriate comparator to the product being investigated and publication bias.
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“pharmaceutical companies, who fund a substantial number of RCTs, are more likely to seek publication of results with statistically positive outcomes. 9”
From Reporting research results: a moral obligation for all researchers. (2007) · cites this paper as [9]
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“Several investigations show strong associations between the source of funding and the conclusions of research articles [ 219 – 222 ].”
From Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): Explanation and Elaboration (2007) · cites this paper as [222]
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“Empirical evidence points toward funding source sometimes being associated with estimated treatment effects [30].”
From CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials (2010) · cites this paper as [30]
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“For example, bias, as indicated by a prevalence of more favourable outcomes, has been demonstrated for clinical research funded by industry compared with studies funded by other sources [257–259].”
From Reporting animal research: Explanation and elaboration for the ARRIVE guidelines 2.0 (2020) · cites this paper as [259]
In the citing paper
“Additionally, different outcomes from the same trials can be a source of pharmaceutical marketing bias.35”
In the citing paper
“Lexchin and colleagues [166] observed that outcomes of reports of randomized trials and meta-analyses of clinical trials funded by the pharmaceutical industry are more likely to favor the sponsor's product compared to studies with other sources of funding.”
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 [166]
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Antonuccio, D. O., Danton, W. G., & McClanahan, T. M. (2003) · American Psychologist · doi:10.1037/0003-066x.58.12.1028 · Cited by 65
Influence of drug company authorship and sponsorship on drug trial outcomes.
Tungaraza, T. E., & Poole, R. (2007) · The British journal of psychiatry : the journal of mental science · doi:10.1192/bjp.bp.106.024547 · Cited by 73
Confronting Power and Corporate Capture at the FAccT Conference
Young, M., Katell, M. A., & Krafft, P. M. (2022) · ACM Conference on Fairness, Accountability, and Transparency (FAccT) · doi:10.1145/3531146.3533194 · Cited by 83
“The case of industry influence in biomedical research is notable for the substantial body of evidence available, which includes systematic surveys spanning quantitative analyses published between 1966-2002 [43] and between 1980-2002 [7].”
BackgroundOkike, K. M., Kocher, M. S., Mehlman, C. T., & Bhandari, M. (2008) · Injury · doi:10.1016/j.injury.2008.02.013 · Cited by 62
Norris, S. L., Holmer, H. K., Burda, B. U., Ogden, L. A., & Fu, R. F. (2012) · PLoS ONE · doi:10.1371/journal.pone.0037413 · Cited by 64
“There are data that suggest an association between author or funder COI and study outcomes [8–11] and between COI and systematic review conclusions [12].”
BackgroundKnowledge Translation: Putting the “Practice” in Evidence-Based Practice
MacDermid, J. C., & Graham, I. D. (2009) · Hand Clinics · doi:10.1016/j.hcl.2008.10.003 · Cited by 64
Harbarth, S., von Dach, E., Pagani, L., Macedo-Viñas, M., Huttner, B. D., Olearo, F., Emonet, S., & Uçkay, İ. (2014) · Journal of Antimicrobial Chemotherapy · doi:10.1093/jac/dku352 · Cited by 64
Relationship between drug company funding and outcomes of clinical psychiatric research
KELLY, R. E., Cohen, L. J., Semple, R. J., Bialer, P. A., Lau, A., BODENHEIMER, A., NEUSTADTER, E., Barenboim, A., & GALYNKER, I. I. (2006) · Psychological Medicine · doi:10.1017/s0033291706008567 · Cited by 64
“This relationship was also found in a number of other, nonblinded studies (Bekelman et al. 2003; Lexchin et al. 2003), but for those studies it is not possible to ascertain the extent to which the raters’ own biases may have influenced their outcome ratings.”
Interventions for female pattern hair loss
van Zuuren, E. J., Fedorowicz, Z., Carter, B., Andriolo, R. B., & Schoones, J. (2012) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd007628.pub3 · Cited by 64
Alfonso, F., Timmis, A., Pinto, F. J., Ambrosio, G., Ector, H., Kułakowski, P., Vardas, P. E., on behalf of the Editors' Network European Society of Cardiology Task Force, Editors' Network members:, Antoniades, L., et al. (2012) · European Heart Journal · doi:10.1093/eurheartj/ehr464 · Cited by 62
Epistemic Corruption, the Pharmaceutical Industry, and the Body of Medical Science
Sismondo, S. (2021) · Frontiers in Research Metrics and Analytics · doi:10.3389/frma.2021.614013 · Cited by 63
“In all of its dimensions, the 2017 meta-analysis arrives at the same or similar results as had earlier quantitative and qualitative reviews (Bekelman et al., 2003; Lexchin et al., 2003; Schott et al., 2010).”
ResultFisher, J. A., Cottingham, M. D., & Kalbaugh, C. A. (2014) · Social Science & Medicine · doi:10.1016/j.socscimed.2014.08.023 · Cited by 70
“For example, some scholars have documented the extent to which industry-funded research generates results from clinical trials that make the drugs look safer and more effective than do independent studies (Healy, 2004; Lexchin et al., 2003).”
BackgroundMatheson, A. (2008) · BioSocieties · doi:10.1017/s1745855208006297 · Cited by 67
“…of trial design with respect to the choice of comparators, study size and duration, treatment regimens and outcome measures may be impacted, such that results generally favour the sponsored product (Bekelman et al., 2003; Heres et al., 2006; Lexchin et al., 2003; Safer, 2002; Sismondo, 2007b).”
BackgroundResultInfluentialStern, S., & Lemmens, T. (2011) · PLoS Medicine · doi:10.1371/journal.pmed.1001070 · Cited by 63
Hanney, S. R., Kuruvilla, S., Soper, B., & Mays, N. (2010) · Health Research Policy and Systems · doi:10.1186/1478-4505-8-11 · Cited by 63
“For example, a systematic review found that trials funded by the pharmaceutical industry tended to have outcomes that favoured products made by the sponsoring companies [52].”
What happened to Popperian falsification? Publishing neutral and negative findings
van Witteloostuijn, A. C. (2016) · Cross Cultural & Strategic Management · doi:10.1108/ccsm-03-2016-0084 · Cited by 63
Naci, H., Dias, S., & Ades, A. E. (2014) · BMJ · doi:10.1136/bmj.g5741 · Cited by 61
Do Cardiology Quality Measures Actually Improve Patient Outcomes?
Chatterjee, P., & Joynt, K. E. (2014) · Journal of the American Heart Association · doi:10.1161/jaha.113.000404 · Cited by 62
Metadata
- Authors
- Lexchin, J., Bero, L. A., Djulbegovic, B., & Clark, O.
- Affiliations
- York University (CA)
- University of California, San Francisco (US)
- Corresponding author
- Lexchin, Joel
- Venue
- BMJ
- Publisher
- BMJ
- Published
- 2003-05-29
- Volume
- 326
- Issue
- 7400
- Pages
- 1167-1170
- ISSN
- 0007-1447 (ISSN-L)
- 0959-8138
- 1468-5833
- PMC
- PMC156458
- OpenAlex
- W2136284733
- Cited by
- 2,147
- References
- 81
- Citations by year
- 2026: 34 · 2025: 49 · 2024: 61 · 2023: 56 · 2022: 57 · 2021: 53 · 2020: 89 · 2019: 74 · 2018: 86 · 2017: 84 · 2016: 82 · 2015: 100 · 2014: 114 · 2013: 107 · 2012: 150
- FWCI
- 10.13
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- www.bmj.com/company/legal-information/terms-conditions/legal-information/tdm-licencepolicy (tdm)
- Locations
- BMJ (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- DigitalGeorgetown (Georgetown University Library) (submittedVersion)
- Topics
- Health Sciences › Nursing › Issues, ethics and legal aspects › Pharmaceutical industry and healthcare
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Global Public Health Policies and Epidemiology
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
- Keywords
- pharmaceutical industry sponsorship, research bias, publication bias, trial quality, research funding sources, comparator selection, conflicts of interest
- MeSH terms
- Clinical Trials as Topic, Drug Industry, Financing, Organized, Publishing, Research, Research Support as Topic
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