Authors' Self-Declared Financial Conflicts of Interest Do Not Impact the Results of Major Cardiovascular Trials

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• 作者：Ashish Aneja ; MD^? ; Ricardo Esquitin ; MD^&dagger ; ; Kshitij Shah ; MD^&Dagger ; ; Rupa Iyengar ; MPH^§ ; ; Rosane Nisenbaum ; PhD^¡Î ; ^¶ ; ; Magda Melo ; MSc^¶ ; ; Shiny Matthewkutty ; MD^§ ; ; Sanjum S. Sethi ; MD^§ ; ; Muhammad Mamdani ; PharmD^¶ ; ; Michael E. Farkouh ; MD ; MSc^§ ; ; ^¶ ; ; ^# ; ^{Michael.Farkouh@mssm.edu}
• 关键词：cardiovascular ; clinical trial ; conflicts of interest ; financial ; industry ; randomized controlled trials
• 刊名：Journal of the American College of Cardiology
• 出版年：2013
• 出版时间：19 March, 2013
• 年：2013
• 卷：61
• 期：11
• 页码：1137-1143
• 全文大小：359 K

文摘

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Objectives

This study assessed whether the results of major, potentially practice-altering cardiovascular trials were influenced by the authors' self-declared financial conflicts of interest (FCOI). Secondary objectives included assessment of trial outcomes by source of funding, by FCOI subtype, and by trial endpoints.

Background

Financial conflicts of interest, ubiquitous in cardiovascular medicine because of significant investigator-industry collaborations, potentially can influence trial outcomes.

Methods

A MEDLINE search was performed using the MeSH term cardiovascular disease limited to randomized controlled trials and clinical trials published from January 1, 2000, through April 15, 2008, in 3 high-impact journals. Two reviewers independently abstracted data from the published article. Chi-square tests, Fisher exact tests, and multivariate logistic regression were used to assess the associations between FCOI and study characteristics and between FCOI and trial outcomes.

Results

Of the 550 articles reviewed, 51.1 % satisfied FCOI criteria, including at least one of the following: stock ownership, employee, speaker's bureau, and consultant). Of the 538 articles providing sponsorship information, 34.6 % reported funding solely by nonprofit organizations, 48.3 % reported funding solely by industry, and 17.1 % reported funding by a combination. Prevalence of FCOI significantly increased with level of industry funding: 21.5 % (none), 50.0 % (shared), 75.0 % (industry solely, n = 281, p < 0.0001). However, no differences in reporting of favorable results were detected when articles were analyzed by self-declared FCOI (60.5 % vs. 59.5 % in those with and without, odds ratio: 1.04, p = 0.81). This result was upheld in multivariate analysis.

Conclusions

Authors' self-declared FCOI and source of funding do not seem to impact outcomes in major cardiovascular clinical trials.