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CMAJ • February 17, 2004; 170 (4)
© 2004 Canadian Medical Association or its licensors

Research
Recherche

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

Mohit Bhandari, Jason W. Busse, Dianne Jackowski, Victor M. Montori, Holger Schünemann, Sheila Sprague, Derek Mears, Emil H. Schemitsch, Dianne Heels-Ansdell and P.J. Devereaux

From the Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ont. (Bhandari, Busse, Jackowski, Montori, Schünemann, Sprague, Mears, Heels-Ansdell, Devereaux); and the Department of Surgery, University of Toronto, Toronto, Ont. (Schemitsch).

Correspondence to: Dr. Mohit Bhandari, Department of Clinical Epidemiology and Biostatistics, McMaster University Medical Centre, 1200 Main St. W, Rm. 2C3, Hamilton ON L8N 3Z5; fax 905 524-3841; bhandari{at}sympatico.ca

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, outcomes, 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 controlling for study quality and sample size.

Results: Among the 332 randomized trials, there were 158 drug trials, 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 funding 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 between 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: Industry-funded trials are more likely to be associated with statistically significant pro-industry findings, both in medical trials and surgical interventions.


Related Article

Randomized clinical trials: What gets published, and when?
Laurence Hirsch
Can. Med. Assoc. J. 2004 170: 481-483. [Full Text] [PDF]



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