Abstract

http://ssrn.com/abstract=2163666
 
 

Citations



 


 



A Randomized Study of How Physicians Interpret Research Funding Disclosures


Aaron S. Kesselheim


Brigham and Women's Hospital/Harvard Medical School; Harvard University - Edmond J. Safra Center for Ethics

Christopher T. Robertson


Harvard Law School; University of Arizona - James E. Rogers College of Law; Harvard University - Edmond J. Safra Center for Ethics

Jessica A. 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 M. Ross


American Board of Internal Medicine (ABIM)

Robert J. Glynn


Harvard University - Brigham and Women's Hospital

Steven Joffe


Dana-Farber Cancer Center

Jerry Avorn


Harvard 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 Series


Not Available For Download

Date posted: October 20, 2012  

Suggested Citation

Kesselheim, Aaron S. and Robertson, Christopher T. and Myers, Jessica A. and Rose, Susannah L. and Gillet, Victoria and Ross, Kathryn M. and Glynn, Robert J. 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: http://ssrn.com/abstract=2163666

Contact Information

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.drugepi.org/portal
Harvard University - Edmond J. Safra Center for Ethics ( email )
124 Mount Auburn Street
Suite 520N
Cambridge, MA 02138
United States

Christopher T. Robertson (Contact Author)
Harvard Law School ( email )
Areeda Hall 127
Cambridge, MA 02138
United States
617-495-9299 (Phone)
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 - Edmond J. Safra Center for Ethics ( email )
124 Mount Auburn Street
Suite 520N
Cambridge, MA 02138
United States

Jessica A. 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 M. Ross
American Board of Internal Medicine (ABIM)
510 Walnut Street
Suite 1700
Philadelphia, PA 19106-3699
United States
Robert J. 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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