Unless a researcher has stock ownership in a company
whose drug is being tested, telling
potential research volunteers about an investigator's
financial interests is unlikely to affect their
willingness to volunteer, a new study shows.
But, the results also show that many research
volunteers put less trust in clinical trial leaders
with financial conflicts.
"Though people's willingness to take part in a
hypothetical clinical trial did not differ
substantially based on the types of financial disclosures,
and many of our study respondents were still
likely to say that they would participate despite
researchers' financial interests, we captured a sense
of unease about some financial ties — particularly
owning company stock — that did affect people's
attitudes and trust in clinical research," said Jeremy
Sugarman, professor at the Johns
Hopkins Berman Institute of Bioethics and the
Johns Hopkins School of Medicine. "We need to keep this
mind as we determine how best to disclose acceptable
financial interests to fully inform potential
The study, led by Sugarman and colleagues at Duke
University, showed that potential research
participants were significantly less trustful of the
researcher if the study's leader owned stock in the
"Ties between companies and physicians who do research
with them are becoming more
transparent, but it's been unclear how well this
information is understood by the public and to what
extent they influence people who consider enrolling in
clinical trials," Sugarman said. "Our study offers
some of the first clear insights on the impact of
disclosures of this information."
For the study, Sugarman and his colleagues at Duke's
School of Medicine and Wake Forest's
schools of Medicine and Law recruited 3,623 adults with
asthma or diabetes from a national database
of individuals who are willing to participate in
Internet-based research. Overall, the recruits, almost
all white, were well-educated and had middle- to
high-income levels. They were located in all regions of
the United States.
Most respondents indicated that the financial
disclosure was less important to their decision
about participating than were such factors as potential
risks and benefits, and the purpose of the
In the experiment, the investigators electronically
sent each patient a description of a
hypothetical clinical trial to test a drug that might treat
his or her particular condition. The
recipients were grouped by the severity of their
Tagged onto the description of the clinical trial was
one of five different financial disclosures:
a generic one suggesting that the study leader might
benefit financially from the study; one saying
that the study leader would be reimbursed only for expenses
pertaining to the trial; one indicating
that the study leader receives extra money from the drug
company for activities such as consulting or
speaking; one indicating that the study leader holds stock
in the drug company; or one indicating that
the researcher's institution holds stock in the drug
The "generic" disclosure, for example, said that the
researcher's institution had reviewed "Dr.
Smith's" financial conflict and concluded that it would not
affect the safety or outcome of the clinical
trial, but offered to provide more information if the
participant wanted it.
The "equity" disclosure said that the amount of
financial investment of Dr. Smith might be
affected by the outcome of the clinical trial and that, in
effect, "Dr. Smith could gain or lose money
depending on what the trial concluded."
The patients were asked to read the material, then
respond to a computer-based survey
indicating their willingness to participate in the trial,
the importance of the financial disclosure in
making their decision, their trust in researchers, their
level of surprise about the financial disclosure
and the perceived quality of the trial's research.
More than two-thirds of the respondents were "not at
all surprised" that the researcher or
institution in which he or she worked might benefit
financially from the hypothetical clinical trial, with
respondents "least surprised" to learn that researchers got
a per capita payment and "most surprised"
to learn that the researcher owned stock.
Fifty-nine percent responded that they felt that the
possibility of financial benefit did nothing
to change their trust in the researcher or the institution,
although 36 percent said their trust was
diminished as a result of the disclosure.
Change in trust levels was not related to the disease
the person had or to its severity.
"A disclosure that the researcher received per capita
payments was least likely to change
respondents' level of trust, whereas a disclosure that the
researcher held an equity interest was most
likely to reduce trust," the study reported.
Sugarman and his colleagues say their results,
published online April 2 in the Journal of General
Internal Medicine, suggest that researchers and
policy-makers involved in clinical trials should
probably pay close attention to the impact of financial
disclosures on potential study subjects.
The study was funded by a grant to Sugarman from the
National Heart, Lung and Blood