A study published ahead of print in the Journal of the American College of Cardiology, by Ashish Aneja (Heart and Vascular Center, MetroHealth Campus of Case Western Reserve University, Cleveland, USA) and others, indicates that investigators in major cardiovascular trials who report financial conflicts of interest are no more likely to publish favourable results than investigators without self-reported financial conflicts of interest.
Aneja et al wrote that financial conflicts of interest are “very important” because of “their potential for undue influence on the judgements of institutions and individuals, along with potentially threatening the integrity of scientific investigation, objectivity of medical care, and quality of patient care.” They added that studies have indicated that patients, research participants, and investigators themselves have concerns about the effect of this influence on research outcomes. The authors commented: “Further, studies have suggested that trials funded by for-profit organisations are more likely to be associated with favourable outcomes compared with those that are funded by non-profit organisations.” As a result of these concerns, Aneja et al reported, there has been a drive towards increased transparency and accountability in medical research (including the recent Institute of Medicine document on reporting conflicts of interest).
Therefore, the aim of their study was to examine the impact of self-reported financial conflicts of interest on the outcome of major randomised cardiovascular trials. The authors focused on cardiovascular trials because of the potential of such trials to “change practice patterns”.
In a Medline search, Aneja et al identified 550 major cardiovascular trials that been published in one of three high-impact journals (The New England Journal of Medicine, The Lancet, or the Journal of the American Medical Association). They found that of these, 281 (51.1%) had self-reported financial conflicts of interest and 269 (48.9%) did not have any such reported conflicts. According to the authors, a financial conflict of interest was present if an author reported stock ownership, being an employee or a consultant, or having a presence on a speakers’ bureau. However if an author received only research funding, they were not considered to have a conflict of interest and were put in the no financial conflicts of interest group (along with authors who did not report any conflicts of interest).
Overall, Aneja et al found that the presence of self-reported conflicts of interests did not significantly increase the likelihood of a trial reporting a significantly beneficial result than the lack of financial conflicts of interests (60.5% vs. 59.5%, respectively, of studies with a beneficial result; p=0.81). The influence of conflicts of interest remained non-significant even after adjusting for type of study, centre location, trial registration, funding source, and intervention type. Furthermore when separated by type of financial interest (ranging from stock ownership to no interest), the distribution of favourable results were similar.
The authors commented: “The results of our study are surprising when evaluated in the light of previously published literature, but perhaps represent the most comprehensive and multidimensional analysis of financial conflicts of interest to date” and concluded “Our findings suggest no significant influence of reported financial conflicts of interest on the likelihood of trial having favourable results.” However, they added that the current strategies for reporting financial interest are in “a state of evolution and require uniform implantation.” They stated “An effective but ongoing surveillance and standardisation of procedures at the individual and institutional level, as suggested by the Institute of Medicine, is required to address this phenomenon.”
Study author Michael Farkouh, chair and director, Peter Munk Centre of Excellence in Multicentre Clinical Trials and director, Heart and Stroke/ Richard Lewar Centre, Toronto, Canada, told Cardiovascular News: “The real message from our study is that we should be tracking the influence of financial conflicts of interest on the outcomes of high impact clinical trials. We propose a strategy that is simple with a finding that was somewhat provocative. In the end we are limited by what authors actually report.”