Cited by 1,697Pharmaceutical industry and healthcareGlobal Public Health Policies and EpidemiologyPolitical Influence and Corporate Strategies

Industry sponsorship and research outcome

Open access
Lundh, Andreas, Lexchin, Joel, Mintzes, Barbara, Schroll, Jeppe B, Bero, Lisa·2017·Cochrane Database of Systematic Reviews

Abstract

BACKGROUND: Clinical research affecting how doctors practice medicine is increasingly sponsored by companies that make drugs and medical devices. Previous systematic reviews have found that pharmaceutical-industry sponsored studies are more often favorable to the sponsor's product compared with studies with other sources of sponsorship. A similar association between sponsorship and outcomes have been found for device studies, but the body of evidence is not as strong as for sponsorship of drug studies. This review is an update of a previous Cochrane review and includes empirical studies on the association between sponsorship and research outcome. OBJECTIVES: To investigate whether industry sponsored drug and device studies have more favorable outcomes and differ in risk of bias, compared with studies having other sources of sponsorship. SEARCH METHODS: In this update we searched MEDLINE (2010 to February 2015), Embase (2010 to February 2015), the Cochrane Methodology Register (2015, Issue 2) and Web of Science (June 2015). In addition, we searched reference lists of included papers, previous systematic reviews and author files. SELECTION CRITERIA: Cross-sectional studies, cohort studies, systematic reviews and meta-analyses that quantitatively compared primary research studies of drugs or medical devices sponsored by industry with studies with other sources of sponsorship. We had no language restrictions. DATA COLLECTION AND ANALYSIS: Two assessors screened abstracts and identified and included relevant papers. Two assessors extracted data, and we contacted authors of included papers for additional unpublished data. Outcomes included favorable results, favorable conclusions, effect size, risk of bias and whether the conclusions agreed with the study results. Two assessors assessed risk of bias of included papers. We calculated pooled risk ratios (RR) for dichotomous data (with 95% confidence intervals (CIs)). MAIN RESULTS: Twenty-seven new papers were included in this update and in total the review contains 75 included papers. Industry sponsored studies more often had favorable efficacy results, RR: 1.27 (95% CI: 1.17 to 1.37) (25 papers) (moderate quality evidence), similar harms results RR: 1.37 (95% CI: 0.64 to 2.93) (four papers) (very low quality evidence) and more often favorable conclusions RR: 1.34 (95% CI: 1.19 to 1.51) (29 papers) (low quality evidence) compared with non-industry sponsored studies. Nineteen papers reported on sponsorship and efficacy effect size, but could not be pooled due to differences in their reporting of data and the results were heterogeneous. We did not find a difference between drug and device studies in the association between sponsorship and conclusions (test for interaction, P = 0.98) (four papers). Comparing industry and non-industry sponsored studies, we did not find a difference in risk of bias from sequence generation, allocation concealment, follow-up and selective outcome reporting. However, industry sponsored studies more often had low risk of bias from blinding, RR: 1.25 (95% CI: 1.05 to 1.50) (13 papers), compared with non-industry sponsored studies. In industry sponsored studies, there was less agreement between the results and the conclusions than in non-industry sponsored studies, RR: 0.83 (95% CI: 0.70 to 0.98) (six papers). AUTHORS' CONCLUSIONS: Sponsorship of drug and device studies by the manufacturing company leads to more favorable efficacy results and conclusions than sponsorship by other sources. Our analyses suggest the existence of an industry bias that cannot be explained by standard 'Risk of bias' assessments.

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Crossref · 10.1002/14651858.mr000033.pub3

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  • There is potential for bias in the review findings arising from funder or sponsor involvement in the review, particularly when the funder or sponsor has an interest in obtaining a particular result.

    “There is potential for bias in the review findings arising from such involvement, particularly when the funder or sponsor has an interest in obtaining a particular result.157”

    From PRISMA 2020 explanation and elaboration: updated guidance and exemplars for reporting systematic reviews (2021) · cites this paper as [157]

    The Background and Authors’ conclusions (pages not provided) say that industry sponsors can influence study outcomes and that sponsored drug and device studies more often report favorable results and conclusions. This supports the concern about an interested sponsor, but the paper examines sponsorship of studies, not funder involvement in producing a review or its findings. (LLM, conf=0.83)

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  • We did not include domains for features that would be expected to operate indirectly, through the included bias domains.

    “We did not include domains for features that would be expected to operate indirectly, through the included bias domains. 14 15”

    From RoB 2: a revised tool for assessing risk of bias in randomised trials (2019) · cites this paper as [14]

    In the Authors’ Conclusions (page unavailable), the review says the Cochrane Handbook does not recommend a separate industry-sponsorship domain because it assumes sponsorship’s influence is mediated through existing bias domains. But the review challenges that assumption and recommends a separate domain for industry bias, so it does not endorse the cited sentence’s general rationale for omitting domains. (LLM, conf=0.82)

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  • The interference of industry bias is likely minimal, given the lack of profits available for CoQ10.

    “The interference of industry bias is likely minimal, in contrast to other subject areas [22,23], given the lack of profits available for CoQ10.”

    From Effect of Coenzyme Q10 on statin-associated myalgia and adherence to statin therapy: A systematic review and meta-analysis (2020) · cites this paper as [23]

    The “Reasons for favorable outcomes in industry sponsored studies” section supports the contrast with other subject areas: it reports an association between industry sponsorship and favorable results in drug and device studies. It does not address CoQ10, its profitability, or whether industry bias in CoQ10 research is minimal (no page number is available in our copy). (LLM, conf=0.84)

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  • Reported mechanisms of sponsorship bias include eligibility criteria, sample size, allocation and blinding, choice of comparators, outcome assessment, statistical analyses and selective outcome reporting.

    “Reported mechanisms of sponsorship bias include eligibility criteria, sample size, allocation and blinding, choice of comparators, outcome assessment, statistical analyses and even practices, such as selective outcome reporting (Lundh et al. 2017; Holman and Elliott 2018; Catalogue of Bias 2019).”

    From Sponsorship bias in randomised controlled trials on postoperative pain after third molar extraction: A meta-research study (2026) · cites this paper as Lundh et al. 2017

    In “Reasons for favorable outcomes in industry sponsored studies” (page not available), the review identifies comparator choice, outcome choice, selective analysis, event coding and selective reporting as possible mechanisms. It does not identify eligibility criteria as a mechanism, and says sponsorship bias may be mediated by factors other than sample size and traditional risk-of-bias measures such as allocation concealment and blinding. (LLM, conf=0.88)

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  • Concerns have been raised that industry sponsorship may bias clinical research, particularly RCTs.

    “Concerns have been raised that industry sponsorship may bias clinical research, particularly RCTs.”

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Research works printed but not linked: 1

  1. [9]9. Bero 2007 {published and unpublished data} Bero L, Oostvogel F, Bacchetti P, Lee K. Factors associated with findings of published trials of drug-drug comparisons: References to other published versions of this review Lexchin 2003

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Authors
Lundh, A., Lexchin, J., Mintzes, B., Schroll, J. B., & Bero, L.
Affiliations
  • University of Southern Denmark (DK)
  • York University (CA)
  • The University of Sydney (AU)
  • Herlev Hospital (DK)
Venue
Cochrane Database of Systematic Reviews
Publisher
Wiley
Published
2017-02-16
Volume
2017
Issue
2
Pages
MR000033-MR000033
ISSN
  • 1361-6137 (ISSN-L)
  • 1465-1858
OpenAlex
W1714980748
Cited by
1,697
References
303
Citations by year
2026: 71 · 2025: 113 · 2024: 98 · 2023: 127 · 2022: 135 · 2021: 131 · 2020: 159 · 2019: 143 · 2018: 152 · 2017: 146 · 2016: 116 · 2015: 104 · 2014: 122 · 2013: 77 · 2012: 3
FWCI
28.60
Type
journal article
Language
en
Open access
Locations
  • Cochrane Database of Systematic Reviews (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
  • University of Southern Denmark Research Portal (University of Southern Denmark) (submittedVersion, other-oa)
Funders
  • Université Paris Diderot
  • National Institute of Mental Health
Topics
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
  • Social Sciences › Business, Management and Accounting › Organizational Behavior and Human Resource Management › Global Public Health Policies and Epidemiology
  • Social Sciences › Business, Management and Accounting › Strategy and Management › Political Influence and Corporate Strategies
Keywords
pharmaceutical industry sponsorship, conflicts of interest, risk of bias, pharmaceutical research, research funding sources, publication bias, selective reporting, peer review, editorial policy, editorial independence
MeSH terms
Data Interpretation, Statistical, Drug Industry, Equipment and Supplies, Industry, Research Support as Topic, Conflict of Interest, Treatment Outcome, Publication Bias, Research Report

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