The first study to document the prevalence and structure of financial conflicts of interest (FCOI) among authors of rheumatoid arthritis (RA) randomized clinical trials (RCTs) found no overall impact of authors' FCOI or of funding source on study outcomes. The study did see, however, that tests were more likely to be positive if an author had received honoraria or consulting fees from the sponsoring drug company.
In a study published online December 10 in the journal Rheumatology, Nasim Ahmed Khan, MD, and colleagues report that the prevalence of FCOI among RA drug trial authors increased from 54.2% of RCTs in 2002-03 to 60.5% of RCTs in 2010-11, and 64.4% of RA RCTs had complete or partial industry funding.
The analysis included 146 non-phase 1, parallel-group, drug therapy RA RCTs published during 2002-03, 2006-07, or 2010-11. Interventions tested covered traditional disease-modifying antirheumatic drugs (DMARDs), biologics, small molecules, and others. The researchers considered the outcome positive if statistically significant results favored the experimental intervention.
Slightly more than half of the trials (56.8%) had at least one author with an FCOI related to the industry sponsor. Of these authors, 43.2% were employees of the sponsoring company, 33.6% had received honoraria or consultation fees, 20.5% had received research grants, and 19.2% owned stock in the company.
Positive study outcomes were not associated with reporting of FCOI in general or with author FCOI, but the trials in which an author had received honoraria or consulting fees were three times more likely to have a positive outcome (adjusted odds ratio, 3.24; 95% confidence interval, 1.06 – 9.88).
Clinical Implications of Findings Uncertain
The clinical implications of these findings are uncertain. Although a Cochrane review found that industry funding of RCTs was associated with increased likelihood of pro-industry results, no such association was observed for the RA RCTs. Furthermore, RCTs with an author FCOI did not have a higher probability of positive outcome than those without an author FCOI.
Clifford Perlis, MD, Keystone Dermatology Partners, King of Prussia, Pennsylvania, who co-authored an analysis of the extent and impact of industry sponsorship COI in dermatology but was not involved in this study, told Medscape Medical News, "Unfortunately, like most other studies about financial conflicts of interest, this study doesn't do much to help clinicians. We know that financial conflicts of interest introduce conscious and unconscious bias. This study seems to document this concerning positive study outcomes.
"However, we still can't quantify the degree of this influence (which is likely to vary depending on the conflict, study, and individual) and we have no tools for recognizing how to address this bias. So, the study highlights (again) that there is a problem, but offers no real insights into how clinicians should address this problem," Perlis continued.
Khan and colleagues suggest the association with authors receiving honoraria or consulting fees might reflect the fact that such authors are often respected experts in their fields and "may contribute to better study questions and design, and patient population or study outcome selection, in a way that enables more precise assessment of the efficacy and safety of an intervention."