A Randomized Study of How Physicians Interpret Research Funding Disclosures

369 New England Journal of Medicine 1119 (2012)

Arizona Legal Studies Discussion Paper No. 12-33

Posted: 20 Oct 2012

See all articles by Aaron S. Kesselheim

Aaron S. Kesselheim

Brigham and Women's Hospital/Harvard Medical School

Christopher T. Robertson

University of Arizona - James E. Rogers College of Law; Harvard University - Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics

Jessica Myers

Harvard University - Brigham and Women's Hospital

Susannah L. Rose

Cleveland Clinic, Department of Bioethics; Case Western Reserve University; Edmond J. Safra Center for Ethics at Harvard University

Victoria Gillet

Harvard University - Brigham and Women's Hospital

Kathryn Ross

American Board of Internal Medicine (ABIM)

Robert Glynn

Harvard University - Brigham and Women's Hospital

Steven Joffe

Dana-Farber Cancer Center

Jerry Avorn

Harvard University - Brigham and Women's Hospital

Date Written: September 20, 2012

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

Suggested Citation

Kesselheim, Aaron S. and Robertson, Christopher T. and Myers, Jessica and Rose, Susannah L. and Gillet, Victoria and Ross, Kathryn and Glynn, Robert and Joffe, Steven and Avorn, Jerry, A Randomized Study of How Physicians Interpret Research Funding Disclosures (September 20, 2012). 369 New England Journal of Medicine 1119 (2012); Arizona Legal Studies Discussion Paper No. 12-33. Available at SSRN: https://ssrn.com/abstract=2163666

Aaron S. Kesselheim

Brigham and Women's Hospital/Harvard Medical School ( email )

1620 Tremont St
Suite 3030
Boston, MA 02120
United States
617-278-0930 (Phone)
617-232-8602 (Fax)

HOME PAGE: http://www.PORTALresearch.org

Christopher T. Robertson (Contact Author)

University of Arizona - James E. Rogers College of Law ( email )

P.O. Box 210176
Tucson, AZ 85721-0176
United States

HOME PAGE: http://www.law.arizona.edu/faculty/getprofile.cfm?facultyid=714

Harvard University - Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics ( email )

23 Everett Street
Cambridge, MA 02155
United States

Jessica Myers

Harvard University - Brigham and Women's Hospital ( email )

75 Francis St.
Boston, MA 02115
United States

Susannah L. Rose

Cleveland Clinic, Department of Bioethics ( email )

9500 Euclid Ave.
Cleveland, OH 44195
United States

Case Western Reserve University ( email )

2511 Overlook Road
Cleveland Heights, OH 44106
United States

Edmond J. Safra Center for Ethics at Harvard University ( email )

124 Mount Auburn Street
Suite 520N
Cambridge, MA 02138
United States

Victoria Gillet

Harvard University - Brigham and Women's Hospital ( email )

75 Francis St.
Boston, MA 02115
United States

Kathryn Ross

American Board of Internal Medicine (ABIM)

510 Walnut Street
Suite 1700
Philadelphia, PA 19106-3699
United States

Robert Glynn

Harvard University - Brigham and Women's Hospital ( email )

75 Francis St.
Boston, MA 02115
United States

Steven Joffe

Dana-Farber Cancer Center ( email )

Boston, MA 02115
United States

Jerry Avorn

Harvard University - Brigham and Women's Hospital ( email )

75 Francis St.
Boston, MA 02115
United States

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