Cardiovascular trial sponsorship significantly impacts findings

(HealthDay)—Large clinical studies that are sponsored by industry are more likely to report favorable outcomes and less likely to report unfavorable outcomes than those sponsored by the National Institutes of Health (NIH), particularly those in the cardiovascular field, according to research published in the Dec. 15 issue of The American Journal of Cardiology.

Noting that previous studies have shown that industry-sponsored (IS) studies are more likely to have positive outcomes, with publication bias a potential confounder, Haris Riaz, M.D., from the Cleveland Clinic, and colleagues used a prepublication database to compare the primary outcome of recent trials based on sponsorship. Recently completed phase III trials involving implementation of a pharmaceutical agent or device were included. Studies were classified as sponsored by the NIH or industry.

The researchers found that based on a comparison of 226 NIH-sponsored trials and 226 IS studies, IS studies were almost four times more likely to report a positive outcome (odds ratio, 3.90; P < 0.0001). In 25 NIH-sponsored and 215 IS cardiovascular trials, favorable outcomes were seven times more likely in IS trials (odds ratio, 7.54; P = 0.0014). IS trials were also less likely to report unfavorable outcomes (odds ratio, 0.11; P < 0.0001).

"In conclusion, the outcomes of large clinical studies—especially cardiovascular—differ considerably on the basis of their funding source, and publication bias appears to have limited influence on these findings," the authors write.

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