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Πέμπτη 2 Αυγούστου 2018

Role of industry funders in oncology RCTs published in high-impact journals and its association with trial conclusions and time to publication

Abstract
Background
Previous studies have shown that industry funded trials are associated with pro-industry conclusions and publication bias. Less is known about the role of industry funders and their influence on trial conclusions and time to publication.
METHODS
We identified all industry funded RCTs published in six high-impact clinical journals between 2014 and 2016 to estimate the prevalence of the role of industry funders in trial design, data collection, data analyses, data interpretation and manuscript writing. Ordinal logistic regression was used to assess the association between the role of industry funders and trial conclusions, which was classified on a 5-point scale. Cox proportional-hazards were used to examine the effect of role of funder on time to publication.
Results
Of the 255 eligible RCTs, industry funders had a role in trial design in 179 (70.2%) trials, data collection in 160 (62.7%) trials, data analyses in 173 (67.8%) trials, data interpretation in 135 (52.9%) trials and manuscript writing in 168 (65.9%) trials. Trials with any role of industry funders had 3.6 times (95% CI, 2.0-6.6) higher odds of having positive conclusions compared with those without role of industry funders. In trials with any role of industry funders, positive trials were published more rapidly than negative trials (hazard ratio=4.3; 95% CI: 2.7-6.7, P<0.001), while for trials without role of industry funders, there was no association (hazard ratio=1.07; 95% CI: 0.57-1.99, P=0.84)
Conclusion
The involvement of industry funders is common in all stages of clinical trials, and was associated with more positive conclusions and more rapid publication of RCTs with positive results.

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