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Factors Associated with Findings of Published Trials of Drug–Drug Comparisons: Why Some Statins Appear More Efficacious than Others

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  • Lisa Bero
  • Fieke Oostvogel
  • Peter Bacchetti
  • Kirby Lee

Abstract

Background: Published pharmaceutical industry–sponsored trials are more likely than non-industry-sponsored trials to report results and conclusions that favor drug over placebo. Little is known about potential biases in drug–drug comparisons. This study examined associations between research funding source, study design characteristics aimed at reducing bias, and other factors that potentially influence results and conclusions in randomized controlled trials (RCTs) of statin–drug comparisons. Methods and Findings: This is a cross-sectional study of 192 published RCTs comparing a statin drug to another statin drug or non-statin drug. Data on concealment of allocation, selection bias, blinding, sample size, disclosed funding source, financial ties of authors, results for primary outcomes, and author conclusions were extracted by two coders (weighted kappa 0.80 to 0.97). Univariate and multivariate logistic regression identified associations between independent variables and favorable results and conclusions. Of the RCTs, 50% (95/192) were funded by industry, and 37% (70/192) did not disclose any funding source. Looking at the totality of available evidence, we found that almost all studies (98%, 189/192) used only surrogate outcome measures. Moreover, study design weaknesses common to published statin–drug comparisons included inadequate blinding, lack of concealment of allocation, poor follow-up, and lack of intention-to-treat analyses. In multivariate analysis of the full sample, trials with adequate blinding were less likely to report results favoring the test drug, and sample size was associated with favorable conclusions when controlling for other factors. In multivariate analysis of industry-funded RCTs, funding from the test drug company was associated with results (odds ratio = 20.16 [95% confidence interval 4.37–92.98], p

Suggested Citation

  • Lisa Bero & Fieke Oostvogel & Peter Bacchetti & Kirby Lee, 2007. "Factors Associated with Findings of Published Trials of Drug–Drug Comparisons: Why Some Statins Appear More Efficacious than Others," PLOS Medicine, Public Library of Science, vol. 4(6), pages 1-10, June.
  • Handle: RePEc:plo:pmed00:0040184
    DOI: 10.1371/journal.pmed.0040184
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    Citations

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    Cited by:

    1. Benhur Ruqsana, 2019. "The Impact of Source of Funding on the Outcome of Clinical Trials in India," Arthaniti: Journal of Economic Theory and Practice, , vol. 18(2), pages 201-216, December.
    2. Anna Lene Seidler & Kylie E Hunter & Nicholas Chartres & Lisa M Askie, 2019. "Associations between industry involvement and study characteristics at the time of trial registration in biomedical research," PLOS ONE, Public Library of Science, vol. 14(9), pages 1-12, September.
    3. Daniel M Cook & Elizabeth A Boyd & Claudia Grossmann & Lisa A Bero, 2007. "Reporting Science and Conflicts of Interest in the Lay Press," PLOS ONE, Public Library of Science, vol. 2(12), pages 1-5, December.
    4. Ferrán Catalá-López & Gabriel Sanfélix-Gimeno & Manuel Ridao & Salvador Peiró, 2013. "When Are Statins Cost-Effective in Cardiovascular Prevention? A Systematic Review of Sponsorship Bias and Conclusions in Economic Evaluations of Statins," PLOS ONE, Public Library of Science, vol. 8(7), pages 1-1, July.
    5. Ferrán Catalá-López & Adolfo Alonso-Arroyo & Rafael Aleixandre-Benavent & Manuel Ridao & Máxima Bolaños & Anna García-Altés & Gabriel Sanfélix-Gimeno & Salvador Peiró, 2012. "Coauthorship and Institutional Collaborations on Cost-Effectiveness Analyses: A Systematic Network Analysis," PLOS ONE, Public Library of Science, vol. 7(5), pages 1-9, May.
    6. Antoine Popelut & Fabien Valet & Olivier Fromentin & Aurélie Thomas & Philippe Bouchard, 2010. "Relationship between Sponsorship and Failure Rate of Dental Implants: A Systematic Approach," PLOS ONE, Public Library of Science, vol. 5(4), pages 1-9, April.
    7. Rima Nakkash & Ahmed Ali & Hala Alaouie & Khalil Asmar & Norbert Hirschhorn & Sanaa Mugharbil & Iman Nuwayhid & Leslie London & Amina Saban & Sabina Faiz Rashid & Md Koushik Ahmed & Cecile Knai & Char, 2020. "Attitudes and practices of public health academics towards research funding from for-profit organizations: cross-sectional survey," International Journal of Public Health, Springer;Swiss School of Public Health (SSPH+), vol. 65(7), pages 1133-1145, September.
    8. Lexchin, Joel & O'Donovan, Orla, 2010. "Prohibiting or 'managing' conflict of interest? A review of policies and procedures in three European drug regulation agencies," Social Science & Medicine, Elsevier, vol. 70(5), pages 643-647, March.
    9. David Krauth & Andrew Anglemyer & Rose Philipps & Lisa Bero, 2014. "Nonindustry-Sponsored Preclinical Studies on Statins Yield Greater Efficacy Estimates Than Industry-Sponsored Studies: A Meta-Analysis," PLOS Biology, Public Library of Science, vol. 12(1), pages 1-10, January.

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