Impact of Funding Source on Clinical Trial Results Including Cardiovascular Outcome Trials

Item Type

Language

English

Abstract

Previous authors have suggested a higher likelihood for industry-sponsored (IS) studies to have positive outcomes than non-IS studies, though the influence of publication bias was believed to be a likely confounder. We attempted to control for the latter using a prepublication database to compare the primary outcome of recent trials based on sponsorship. We used the "advanced search" feature in the clinicaltrials.gov website to identify recently completed phase III studies involving the implementation of a pharmaceutical agent or device for which primary data were available. Studies were categorized as either National Institutes of Health (NIH) sponsored or IS. Results were labeled "favorable" if the results favored the intervention under investigation or "unfavorable" if the intervention fared worse than standard medical treatment. We also performed an independent literature search to identify the cardiovascular trials as a case example and again categorized them into IS versus NIH sponsored. A total of 226 studies sponsored by NIH were found. When these were compared with the latest 226 IS studies, it was found that IS studies were almost 4 times more likely to report a positive outcome (odds ratio [OR] 3.90, 95% confidence interval [CI] 2.6087 to 5.9680, p <0.0001). As a case example of a specialty, we also identified 25 NIH-sponsored and 215 IS cardiovascular trials, with most focusing on hypertension therapy (31.6%) and anticoagulation (17.9%). IS studies were 7 times more likely to report favorable outcomes (OR 7.54, 95% CI 2.19 to 25.94, p = 0.0014). They were also considerably less likely to report unfavorable outcomes (OR 0.11, 95% CI 0.04 to 0.26, 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.

Subject

Humans
Research Support as Topic
United States
Cardiovascular Diseases
Clinical Trials as Topic
Financial Management

Publication Year

2015

Publication Date

2015-12-15

Journal abreviation

Am. J. Cardiol.

Source

PMID: 26611124PubMed

License

ISSN

1879-1913

Link Attachment

http://www.ncbi.nlm.nih.gov/pubmed/26611124

Physical Description

vol. 116, n. 12, pp. 1944-1947

Citer cette ressource

Impact of Funding Source on Clinical Trial Results Including Cardiovascular Outcome Trials, dans Science & Ignorance, consulté le 21 Novembre 2024, https://ignorancestudies.inist.fr/s/science-ignorance/item/4630

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