Industry sponsorship and research outcome (Review)

Lundh A, Sismondo S, Lexchin J, Busuioc OA, Bero L

This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library
2012, Issue 12
http://www.thecochranelibrary.com

Industry sponsorship and research outcome (Review)

Copyright 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

[Methodology Review]

Industry sponsorship and research outcome

Andreas Lundh1 , Sergio Sismondo2 , Joel Lexchin3 , Octavian A Busuioc2 , Lisa Bero4
1 The

Nordic Cochrane Centre, Rigshospitalet, Copenhagen, Denmark. 2 Department of Philosophy, Queens University, Kingston,
Canada. 3 School of Health Policy and Management, York University, Toronto, Canada. 4 Department of Clinical Pharmacy and Institute
for Health Policy Studies, University of California San Francisco, San Francisco, California, USA
Contact address: Andreas Lundh, The Nordic Cochrane Centre, Rigshospitalet, Blegdamsvej 9, 7811, Copenhagen, DK-2100, Denmark. al@cochrane.dk.
Editorial group: Cochrane Methodology Review Group.
Publication status and date: Edited (no change to conclusions), comment added to review, published in Issue 7, 2013.
Review content assessed as up-to-date: 30 September 2010.
Citation: Lundh A, Sismondo S, Lexchin J, Busuioc OA, Bero L. Industry sponsorship and research outcome. Cochrane Database of
Systematic Reviews 2012, Issue 12. Art. No.: MR000033. DOI: 10.1002/14651858.MR000033.pub2.
Copyright 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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 sponsors
product compared with studies with other sources of sponsorship. This review is an update using more stringent methodology and also
investigating sponsorship of device studies.
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
We searched MEDLINE (1948 to September 2010), EMBASE (1980 to September 2010), the Cochrane Methodology Register (Issue
4, 2010) and Web of Science (August 2011). 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 identified potentially relevant papers, and a decision about final inclusion was made by all authors. 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).
Industry sponsorship and research outcome (Review)
Copyright 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Main results
Forty-eight papers were included. Industry sponsored studies more often had favorable efficacy results, risk ratio (RR): 1.32 (95%
confidence interval (CI): 1.21 to 1.44), harms results RR: 1.87 (95% CI: 1.54 to 2.27) and conclusions RR: 1.31 (95% CI: 1.20 to
1.44) compared with non-industry sponsored studies. Ten papers reported on sponsorship and effect size, but could not be pooled due
to differences in their reporting of data. The results were heterogeneous; five papers found larger effect sizes in industry sponsored studies
compared with non-industry sponsored studies and five papers did not find a difference in effect size. Only two papers (including 120
device studies) reported separate data for devices and we did not find a difference between drug and device studies on the association
between sponsorship and conclusions (test for interaction, P = 0.23). Comparing industry and non-industry sponsored studies, we did
not find a difference in risk of bias from sequence generation, allocation concealment and follow-up. However, industry sponsored
studies more often had low risk of bias from blinding, RR: 1.32 (95% CI: 1.05 to 1.65), 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: 0.84 (95% CI: 0.70 to 1.01).
Authors conclusions
Sponsorship of drug and device studies by the manufacturing company leads to more favorable 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.

PLAIN LANGUAGE SUMMARY

Industry sponsorship and research outcome
Results from clinical studies on drugs and medical devices affect how doctors practice medicine and thereby the treatments offered to
patients. However, clinical research is increasingly sponsored by companies that make these products, either because the companies
directly perform the studies, or fully or partially fund them. Previous research has found that pharmaceutical industry sponsored studies
tend to favor the sponsors drugs much more than studies with any other sources of sponsorship. This suggests that industry sponsored
studies are biased in favor of the sponsors products.
This review is an update of a previous review on this topic that looked only at drug studies. It uses more rigorous methodology and
also investigates sponsorship of medical device studies. The primary aim of the review was to find out whether the published results
and overall conclusions of industry sponsored drug and device studies were more likely to favor the sponsors products, compared with
studies with other sources of sponsorship. The secondary aim was to find out whether such industry sponsored studies used methods
that increase the risk of bias, again compared with studies with other sources of sponsorship. We did a comprehensive search of all
relevant papers published before September 2010 and included 48 papers in our review.
Industry sponsored drug and device studies more often had favorable efficacy results, (risk ratio (RR): 1.32, 95% confidence interval
(CI): 1.21 to 1.44), harms results (RR: 1.87, 95% CI: 1.54 to 2.27) and overall conclusions (RR: 1.31, 95% CI: 1.20 to 1.44), compared
with non-industry sponsored drug and device studies. We did not find a difference between industry and non-industry sponsored
studies with respect to standard factors that may increase the risk of bias, except for blinding: industry sponsored studies reported
satisfactory blinding more often than non-industry sponsored studies. We did not find a difference between drug and device studies
on the association between sponsorship and conclusions. In industry sponsored studies, there was less agreement between the results
and the conclusions than in non-industry sponsored studies, RR: 0.84 (95% CI: 0.70 to 1.01). Our analysis suggests that industry
sponsored drug and device studies are more often favorable to the sponsors products than non-industry sponsored drug and device
studies due to biases that cannot be explained by standard Risk of bias assessment tools.

Industry sponsorship and research outcome (Review)

Copyright 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.