Public Release: 

Clinical trial patients don't care about study sponsors or physician conflicts of interest

Johns Hopkins Medicine

Many patients will volunteer for a clinical trial if asked, even if the physician who inquires is a stockholder in the sponsoring company or has other potential conflicts of interest, a Johns Hopkins study demonstrates.

Results of the study, to be presented Nov. 11 at the American Heart Association's 76th annual Scientific Sessions in Orlando, Fla., also suggest that the majority of clinical trial patients don't care if their physician discloses such conflicts of interest to them.

"There's been an incredible push by academicians and health policy makers to make sure conflicts of interest are minimized," says Joel B. Braunstein, M.D., M.B.A., lead author of the study and an assistant professor of medicine at Hopkins. "While ethically, this is readily justified, our study quite surprisingly suggests that patients don't really care about these relationships. A patient's decision to enroll in a clinical trial involves many more factors, including interest in finding a new medication that might help him or her."

Braunstein and colleagues approached 1,132 patients from 13 Maryland-based cardiology and internal medicine outpatient clinics about participating in a hypothetical clinical trial for a new drug to help prevent heart attack. At random, they told patients that either there was no conflict of interest for the physician involved, the physician would receive a $2,000 finder's fee for each patient enrolled in the study, or the physician was a patent holder of the study drug. They also presented to patients one of three randomly assigned sponsors: a nonprofit research foundation, the U.S. government, or a pharmaceutical company.

Of the patients approached, 789 (70 percent) completed a questionnaire about clinical trial participation. About a third of all patients expressed interest in participation, whether or not there was a disclosed conflict of interest. More than half of the patients (55 percent) said they felt it was not very important for investigators to disclose their conflict of interest during trial recruitment.

More patients said they were willing to participate in a trial sponsored by a pharmaceutical company (39 percent) than by the government (34 percent) or a nonprofit foundation (31 percent). However, patients also reported more trust in a nonprofit foundation than a pharmaceutical company.

"Many people don't trust pharmaceutical companies because they feel they are being overcharged for medications," Braunstein adds. "But given a chance to get involved in the testing of a new drug that may provide them some health benefit, they want to do this."

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The study was sponsored by the Robert Wood Johnson Foundation. Coauthors were Steven Schulman, M.D., and Neil R. Powe, M.D., M.P.H., M.B.A.

Abstract # 3423: Braunstein, J.B. et al, "Impact of Investigator Financial Conflicts of Interest and Industry Sponsorship of Clinical Trials on Patient Participation"

Links:
Johns Hopkins' Division of Cardiology
http://www.hopkinsmedicine.org/cardiology/

American Heart Association - 76th Scientific Sessions
http://www.scientificsessions.org/

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