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, 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," said Joel B. Braunstein, lead author of the
study and an assistant professor of
medicine in
the Johns Hopkins School of Medicine. "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 either that there was no
conflict of interest for the physician involved, that the
physician would receive a $2,000 finder's fee for each
patient enrolled in the study or that 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 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 in a
pharmaceutical company.
"Many people don't trust pharmaceutical companies
because they feel they are being overcharged for
medications," Braunstein said. "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."
The study was sponsored by the Robert Wood Johnson
Foundation. Coauthors were Steven Schulman and Neil R.
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