Cited by 183Pharmaceutical industry and healthcareEthics in Clinical ResearchStatistical Methods in Clinical Trials

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A Randomized Study of How Physicians Interpret Research Funding Disclosures

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Kesselheim, Aaron S., Robertson, Christopher T., Myers, Jessica A., Rose, Susannah L., Gillet, Victoria, Ross, Kathryn M., Glynn, Robert J., Joffe, Steven, Avorn, Jerry·2012·New England Journal of Medicine

DOI 10.1056/nejmsa1202397PMC PMC3538846

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Abstract

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

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Authors: Kesselheim, A. S., Robertson, C. T., Myers, J. A., Rose, S. L., Gillet, V., Ross, K. M., Glynn, R. J., Joffe, S., & Avorn, J.
Affiliations: Brigham and Women's Hospital (US)
Harvard University (US)
Cleveland Clinic (US)
American Board of Internal Medicine (US)
Dana-Farber Cancer Institute (US)
ORCID: Kesselheim, Aaron S.
Robertson, Christopher T.
Rose, Susannah L.
Ross, Kathryn M.
Glynn, Robert J.
Joffe, Steven
Avorn, Jerry
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2012-09-20
Volume: 367
Issue: 12
Pages: 1119-1127
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmsa1202397
PMC: PMC3538846
OpenAlex: W2036907307
Cited by: 183
References: 54
Citations by year: 2026: 3 · 2025: 5 · 2024: 7 · 2023: 6 · 2022: 9 · 2021: 5 · 2020: 5 · 2019: 13 · 2018: 26 · 2017: 13 · 2016: 23 · 2015: 15 · 2014: 28 · 2013: 22 · 2012: 3
FWCI: 24.59
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
Europe PMC (PubMed Central) (acceptedVersion)
PubMed Central (acceptedVersion)
Funders: Harvard Catalyst
ABIM Foundation
Agency for Healthcare Research and Quality (K08HS018465, K08HS18465-01)
National Cancer Institute (R25CA092203)
Topics: Health Sciences › Nursing › Issues, ethics and legal aspects › Pharmaceutical industry and healthcare
Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Keywords: clinical trial funding, research funding disclosure, pharmaceutical industry sponsorship, NIH funding, prescribing patterns, conflicts of interest, research integrity, generalizability of trial results, bias in clinical trials
MeSH terms: Data Collection, Drug Evaluation, Drug Industry, Humans, Internal Medicine, National Institutes of Health (U.S.), Physicians, Regression Analysis, Research Design, Research Support as Topic, United States

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A Randomized Study of How Physicians Interpret Research Funding Disclosures

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