A study published Feb. 6 in the Journal of the American College of Cardiology showed that authors' self-declared financial conflicts of interest (FCOI) and source of funding were not found to impact outcomes in major cardiovascular clinical trials.

Out of the 550 cardiovascular disease articles reviewed on randomized controlled trials and clinical trials published from January 2000 through April 2008 in The New England Journal of Medicine, The Journal of the American Medical Association, and The Lancet, 51.1 percent, or 281 articles, satisfied FCOI criteria, and included either: stock ownership, employee, speaker's bureau, or consultant.

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Results showed of the 538 articles providing sponsorship information, 34.6 percent reported funding solely by nonprofit organizations, 48.3 percent reported funding solely by industry, and 17.1 percent reported funding by a combination. Prevalence of FCOI significantly increased with level of industry funding: 21.5 percent (none), 50.0 percent (shared), 75.0 percent (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 percent vs. 59.5 percent in those with and without, odds ratio: 1.04, p = 0.81).

The authors conclude that their findings "suggest no significant influence of reported FCOI on the likelihood of a trial having favorable results." They add that strategies for self-reporting of FCOI are in flux and "an effective but ongoing surveillance and standardization of procedures at the individual and institutional level as suggested by the Institute of Medicine, is required to address this phenomenon."

In a related editorial comment, Robert M. Califf, MD, MACC, Department of Medicine, Duke University Medical Center, Durham, North Carolina, notes "these are provocative findings, but their generalizability is limited by the methods used in the study." Califf explains that the journals used aren’t representative of the general medical literature, and that previous studies have shown that self-reported FCOI is inaccurate. Additionally, he explains that nonfinancial conflict of interest should be a factor that is explored. "A systematic approach to interrogating this issue, coupled with increasingly comprehensive sources for data analysis, has the potential to reduce the amount of conflicting information about conflicts of interest," he adds.

Commenting on the study, Harlan M. Krumholz, MD, SM, FACC, Harold H. Hines, Jr., profess or medicine and epidemiology and public health, Yale University School of Medicine, notes, "the problem is that this type of study cannot detect influence. We do not know what the results would have been had these studies been conducted by people who were without FCOI. In addition, we tend to lump FCOI together, but there are quite a range of relationships and arrangements. What we want are transparent processes in place so that all the decisions that go into a trial are publicly visible – and in that atmosphere the FCOI do not matter – when the science is clear at all levels of detail, then it can be debated without concern that unseen bias is at work."

Keywords: Universities, National Academies of Science, Engineering, and Medicine, U.S., Health and Medicine Division, New England, Prevalence, Public Health, Medicine, Cardiovascular Diseases, United States, North Carolina

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