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 more than studies with any other sources of sponsorship. This suggests that industry sponsored studies are biased in favor of the sponsor’s products.
This review is an update of a previous review that looked at sponsorship of drug and 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. In this update, we carried out a comprehensive search of all relevant papers of empirical studies published from 2010 to February 2015 and included 27 new papers, yielding a total of 75 papers included in our review.
Industry sponsored drug and device studies more often had efficacy results that were favorable to the sponsors' products, (risk ratio (RR): 1.27, 95% confidence interval (CI): 1.17 to 1.37), similar harms results (RR: 1.37, 95% CI: 0.64 to 2.93) and favorable overall conclusions (RR: 1.34, 95% CI: 1.19 to 1.51), 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 methodological factors that may increase the risk of bias, except for blinding: industry sponsored studies reported satisfactory blinding more often than 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).We did not find a difference between drug and device studies in the association between sponsorship and conclusions. Our analysis suggests that industry sponsored drug and device studies are more often favorable to the sponsor’s products than non-industry sponsored drug and device studies due to biases that cannot be explained by standard 'Risk of bias' assessment tools.
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.
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.
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.
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.
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.
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)).
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).