Clinical research is widely sponsored by drug and device companies. We investigated 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. This review is an update of a previous Cochrane review.
In this update we searched MEDLINE and Embase (2010 to February 2015), Cochrane Methodology Register (2015, Issue 2) and Web of Science (June 2015). We included empirical studies that quantitatively compared primary research studies of drugs or medical devices sponsored by industry with studies with other sources of sponsorship. Two assessors included papers, extracted data and assessed risk of bias. Outcomes included favorable results, favorable conclusions, effect size, risk of bias and whether conclusions agreed with results.
We included 27 additional papers in this update (review now includes 75 papers). Industry sponsored studies more often had favorable efficacy results, RR: 1.27 (95% CI 1.17–1.37), no difference in harms results RR: 1.37 (95% CI 0.64–2.93) and more often favorable conclusions RR: 1.34 (95% CI 1.19–1.51) compared with non-industry sponsored studies. Nineteen papers reported on sponsorship and efficacy effect size, but could not be pooled due to differences in reporting of data and heterogeneity of results. 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 1.05–1.50), compared with non-industry sponsored studies.
Drug and device studies sponsored by manufacturing companies have more favorable efficacy results and conclusions than studies sponsored by other sources.
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We thank Jeremy Cullis (clinical librarian) at Macquarie University for developing the search strategy and running the database searches of this update. We thank the authors of the included papers for sharing their raw data. We thank Sergio Sismondo and Octavian A. Busuioc who co-authored the previous review. The authors were personally salaried by their institution during the period of the review. The study received no external funding.
Conflicts of interest
All review authors are authors of the some of the previous reviews and included studies. In 2015–2018, Joel Lexchin was a paid consultant on three projects: one looking at indication-based prescribing (United States Agency for Healthcare Research and Quality), a second to develop principles for conservative diagnosis (Gordon and Betty Moore Foundation) and a third deciding what drugs should be provided free of charge by general practitioners (Government of Canada, Ontario Supporting Patient Oriented Research Support Unit and the St Michael’s Hospital Foundation). He also received payment for being on a panel that discussed a pharmacare plan for Canada (Canadian Institute, a for-profit organization). He is currently a member of research groups that are receiving money from the Canadian Institutes of Health Research and the Australian National Health and Medical Research Council. He is member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare. In 2015 and 2016, Barbara Mintzes was retained as an expert witness by the law firm representing the plaintiffs in an application for a Canadian class action on cardiovascular risks of testosterone supplements. She was a member of the Health Action International—Europe Association Board from 2012 to 2015. The review authors have no other relevant interests.
Republished in Intensive Care Medicine with permission of © The Cochrane Collaboration. This review is an abridged version of a Cochrane Review previously published in the Cochrane Database of Systematic Reviews: Lundh A, Lexchin J, Mintzes B, Schroll JB, Bero L. Industry sponsorship and research outcome. Cochrane Database of Systematic Reviews 2017, Issue 2. Art. No.: MR000033. https://doi.org/10.1002/14651858.mr000033.pub3 (see http://www.cochranelibrary.com for information). Cochrane Reviews are regularly updated as new evidence emerges and in response to feedback, and Cochrane Database of Systematic Reviews should be consulted for the most recent version of the review.
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Lundh, A., Lexchin, J., Mintzes, B. et al. Industry sponsorship and research outcome: systematic review with meta-analysis. Intensive Care Med 44, 1603–1612 (2018). https://doi.org/10.1007/s00134-018-5293-7
- Industry sponsorship
- Conflicts of interest
- Clinical trials
- Methodological quality