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

Publication ,  Journal Article
Riaz, H; Raza, S; Khan, MS; Riaz, IB; Krasuski, RA
Published in: Am J Cardiol
December 15, 2015

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.

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Published In

Am J Cardiol

DOI

EISSN

1879-1913

Publication Date

December 15, 2015

Volume

116

Issue

12

Start / End Page

1944 / 1947

Location

United States

Related Subject Headings

  • United States
  • Research Support as Topic
  • Humans
  • Financial Management
  • Clinical Trials as Topic
  • Cardiovascular System & Hematology
  • Cardiovascular Diseases
  • 3201 Cardiovascular medicine and haematology
  • 1102 Cardiorespiratory Medicine and Haematology
 

Citation

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Riaz, H., Raza, S., Khan, M. S., Riaz, I. B., & Krasuski, R. A. (2015). Impact of Funding Source on Clinical Trial Results Including Cardiovascular Outcome Trials. Am J Cardiol, 116(12), 1944–1947. https://doi.org/10.1016/j.amjcard.2015.09.034
Riaz, Haris, Sajjad Raza, Muhammad Shahzeb Khan, Irbaz Bin Riaz, and Richard A. Krasuski. “Impact of Funding Source on Clinical Trial Results Including Cardiovascular Outcome Trials.Am J Cardiol 116, no. 12 (December 15, 2015): 1944–47. https://doi.org/10.1016/j.amjcard.2015.09.034.
Riaz H, Raza S, Khan MS, Riaz IB, Krasuski RA. Impact of Funding Source on Clinical Trial Results Including Cardiovascular Outcome Trials. Am J Cardiol. 2015 Dec 15;116(12):1944–7.
Riaz, Haris, et al. “Impact of Funding Source on Clinical Trial Results Including Cardiovascular Outcome Trials.Am J Cardiol, vol. 116, no. 12, Dec. 2015, pp. 1944–47. Pubmed, doi:10.1016/j.amjcard.2015.09.034.
Riaz H, Raza S, Khan MS, Riaz IB, Krasuski RA. Impact of Funding Source on Clinical Trial Results Including Cardiovascular Outcome Trials. Am J Cardiol. 2015 Dec 15;116(12):1944–1947.
Journal cover image

Published In

Am J Cardiol

DOI

EISSN

1879-1913

Publication Date

December 15, 2015

Volume

116

Issue

12

Start / End Page

1944 / 1947

Location

United States

Related Subject Headings

  • United States
  • Research Support as Topic
  • Humans
  • Financial Management
  • Clinical Trials as Topic
  • Cardiovascular System & Hematology
  • Cardiovascular Diseases
  • 3201 Cardiovascular medicine and haematology
  • 1102 Cardiorespiratory Medicine and Haematology