Association between industry funding and statistically significant pro-industry findings in medical and surgical randomized trials

Bhandari, Mohit; Busse, Jason W.; Jackowski, Dianne; Montori, Victor M.; Schünemann, Holger; Sprague, Sheila; Mears, Derek; Schemitsch, Emil H.; Heels-Ansdell, Dianne; Devereaux, P. J.
February 2004
CMAJ: Canadian Medical Association Journal;2/17/2004, Vol. 170 Issue 4, p477
Academic Journal
Background: Conflicting reports exist in the medical literature regarding the association between industry funding and published research findings. In this study, we examine the association between industry funding and the statistical significance of results in recently published medical and surgical trials. Methods: We examined a consecutive series of 332 randomized trials published between January 1999 and June 2001 in 8 leading surgical journals and 5 medical journals. Each eligible study was independently reviewed for methodological quality using a 21-point index with 5 domains: randomization, out-comes, eligibility criteria, interventions and statistical issues. Our primary analysis included studies that explicitly identified the primary outcome and reported it as statistically significant. For studies that did not explicitly identify a primary outcome, we defined a "positive" study as one with at least 1 statistically significant outcome measure. We used multivariable regression analysis to determine whether there was an association between reported industry funding and trial results, while con-trolling for study quality and sample size. Results: Among the 332 randomized trials, there were 158 drug tri-als, 87 surgical trials and 87 trials of other therapies. In 122 (37%) of the trials, authors declared industry funding. An unadjusted analysis of this sample of trials revealed that industry fund-ing was associated with a statistically significant result in favour of the new industry product (odds ratio [OR] 1.9, 95% confidence interval [CI] 1.3--3.5). The association remained significant after adjustment for study quality and sample size (adjusted OR 1.8, 95% CI 1.1--3.0). There was a nonsignificant difference be-tween surgical trials (OR 8.0, 95% CI 1.1--53.2) and drug trials (OR 1.6, 95% CI 1.1--2.8), both of which were likely to have a pro-industry result (relative OR 5.0, 95% CI 0.7--37.5, p= 0.14). Interpretation: Indus.


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