The effects of clinical-trial funding on the interpretation of trial results are poorly understood. We examined how such support affects physicians' reactions to trials with a high, medium, or low level of methodologic rigor.
We presented 503 board-certified internists with abstracts that we designed describing clinical trials of three hypothetical drugs. The trials had high, medium, or low methodologic rigor, and each report included one of three support disclosures: funding from a pharmaceutical company, NIH funding, or none. For both factors studied (rigor and funding), one of the three possible variations was randomly selected for inclusion in the abstracts. Follow-up questions assessed the physicians' impressions of the trials' rigor, their confidence in the results, and their willingness to prescribe the drugs.
The 269 respondents (53.5% response rate) perceived the level of study rigor accurately. Physicians reported that they would be less willing to prescribe drugs tested in low-rigor trials than those tested in medium-rigor trials (odds ratio, 0.64; 95% confidence interval [CI], 0.46 to 0.89; P=0.008) and would be more willing to prescribe drugs tested in high-rigor trials than those tested in medium-rigor trials (odds ratio, 3.07; 95% CI, 2.18 to 4.32; P<0.001). Disclosure of industry funding, as compared with no disclosure of funding, led physicians to downgrade the rigor of a trial (odds ratio, 0.63; 95% CI, 0.46 to 0.87; P=0.006), their confidence in the results (odds ratio, 0.71; 95% CI, 0.51 to 0.98; P=0.04), and their willingness to prescribe the hypothetical drugs (odds ratio, 0.68; 95% CI, 0.49 to 0.94; P=0.02). Physicians were half as willing to prescribe drugs studied in industry-funded trials as they were to prescribe drugs studied in NIH-funded trials (odds ratio, 0.52; 95% CI, 0.37 to 0.71; P<0.001). These effects were consistent across all levels of methodologic rigor.
Physicians discriminate among trials of varying degrees of rigor, but industry sponsorship negatively influences their perception of methodologic quality and reduces their willingness to believe and act on trial findings, independently of the trial's quality. These effects may influence the translation of clinical research into practice.
"Of more direct relevance to the present study is the fact that recipients of FCOI disclosures often seem little affected by them or are influenced by them in unpredictable ways. Although one study found physicians less likely to prescribe drugs that had been studied in trials funded by industry, as compared to NIHsponsored studies (Kesselheim et al. 2012), other work has shown that while medical journal readers discount the credibility of research authored by employees of an industrial sponsor, they do not similarly discount research authored by academics with corporate ties (Shroter et al. 2004). Another investigation showed that while physicians believe they should discount drug research involving financial conflicts of interest, they fail to do so when evaluating single trials in isolation from others (Silverman et al. 2010). "
[Show abstract][Hide abstract] ABSTRACT: This study explored how disclosure of financial conflicts of interest (FCOI) influences naïve or "lay" individuals' perceptions of the ethicality of researcher conduct. On a between-subjects basis, participants read ten scenarios in which researchers disclosed or failed to disclose relevant financial conflicts of interest. Participants evaluated the extent to which each vignette represented a FCOI, its possible influence on researcher objectivity, and the ethics of the financial relationship. Participants were then asked if they had completed a college-level ethics course. Results indicated that FCOI disclosure significantly influenced participants' perceptions of the ethicality of the situation, but only marginally affected perceptions of researcher objectivity and had no significant influence on perceptions of the existence of FCOIs. Participants who had previously completed a college-level ethics course appeared more sensitive to the importance of FCOI disclosure than those who lacked such background. This result suggests that formal ethical training may help individuals become more critical consumers of scientific research.
"For example, several studies have shown conflicting results
in terms of physicians’ financial disclosures on patient trust [10,11], demonstrating that how the disclosure is given and interpreted is
critical. A recent randomized trial showed that disclosure of research funding
significantly influenced how physicians viewed the methodological quality of the
trial and their willingness to change their practice based on the results . "
[Show abstract][Hide abstract] ABSTRACT: In 2005, the International Patient Decisions Aid Standards (IPDAS) Collaboration developed quality criteria for patient decisions aids; one of the quality dimensions dealt with disclosure of conflicts of interest (COIs). The purposes of this paper are to review newer evidence on dealing with COI in the development of patient decision aids and to readdress the theoretical justification and definition for this quality dimension.
The committee conducted a primary systematic literature review to seek published research addressing the question, "What is the evidence that disclosure of COIs in patient decision aids reduces biased decision making?" A secondary literature review included a systematic search for recent meta-analyses addressing COIs in other spheres of health care, including research and publication, medical education, and clinical care.
No direct evidence was found addressing this quality dimension in the primary literature review. The secondary review yielded a comprehensive Institute of Medicine report, as well as four relevant meta-analyses addressing disclosure of COIs in health care. They revealed a broad consensus that disclosure of COIs is desirable in such areas as research publication, guideline development, medical education, and clinical care.
The committee recommends the criteria that are currently used to operationally define the quality dimension "disclosing conflicts of interest" be changed as follows (changes in italics):
BMC Medical Informatics and Decision Making 11/2013; 13 Suppl 2(Suppl 2):S3. DOI:10.1186/1472-6947-13-S2-S3 · 1.83 Impact Factor
Data provided are for informational purposes only. Although carefully collected, accuracy cannot be guaranteed. The impact factor represents a rough estimation of the journal's impact factor and does not reflect the actual current impact factor. Publisher conditions are provided by RoMEO. Differing provisions from the publisher's actual policy or licence agreement may be applicable.