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A Randomized Study of How Physicians Interpret Research Funding DisclosuresAaron S. KesselheimBrigham and Women's Hospital/Harvard Medical School; Harvard University - Edmond J. Safra Center for Ethics Christopher T. RobertsonUniversity of Arizona - James E. Rogers College of Law; Harvard University - Edmond J. Safra Center for Ethics Jessica A. MyersHarvard University - Brigham and Women's Hospital Susannah RoseCleveland Clinic; Edmond J. Safra Center for Ethics at Harvard University Victoria GilletHarvard University - Brigham and Women's Hospital Kathryn M. RossAmerican Board of Internal Medicine (ABIM) Robert J. GlynnHarvard University - Brigham and Women's Hospital Steven JoffeDana-Farber Cancer Center Jerry AvornHarvard University - Brigham and Women's Hospital September 20, 2012 369 New England Journal of Medicine 1119 (2012) Arizona Legal Studies Discussion Paper No. 12-33 Abstract: 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.
Keywords: clinical trial funding, trial results, industry sponsorship Accepted Paper SeriesDate posted: October 20, 2012Suggested CitationContact Information
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