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

Study Questions:

What is the impact of authors’ self-declared financial conflicts of interest (FCOI) on the results of major, potentially practice-altering cardiovascular trials?

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 three 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:

The authors concluded that authors’ self-declared FCOI and source of funding do not seem to impact outcomes in major cardiovascular clinical trials.

Perspective:

This study reported that authors’ self-declared FCOI are ubiquitous in major cardiovascular clinical trials and do not seem to have an impact on their outcomes. It should be noted that the results of this study are based on self-declared FCOI and are of concern because a recent study suggests significant under-reporting of FCOI by guideline authors. Current strategies for reporting of FCOI are in a state of evolution and require more uniform implementation. An effective ongoing surveillance and standardization of procedures at the individual and institutional level, as suggested by the Institute of Medicine, is needed to address this phenomenon further.

Keywords: Conflict of Interest, Chi-Square Distribution, Prevalence, Industry, Cardiology, Financial Support, Cardiovascular Diseases, Biological Evolution, Institute of Medicine (U.S.), United States


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