Clinical Trial Volunteers Uneasy About Some Financial Ties
FRIDAY, April 11 -- Many volunteers in clinical studies aren't overly concerned if researchers have financial conflicts, but there is some loss of trust, suggests a U.S. study.
"Though peoples' willingness to take part in a hypothetical clinical trial did not suffer 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 affects peoples' attitudes and trust in clinical research," Dr. Jeremy Sugarman, a professor at the Johns Hopkins Berman Institute of Bioethics and The Johns Hopkins School of Medicine, said in a prepared statement.
"We need to keep this in mind as we determine how best to disclose acceptable financial interests to fully inform potential study participants," Sugarman said.
He and colleagues at Duke University and Wake Forest University sent a description of a hypothetical clinical drug trial to 3,623 adults with asthma or diabetes. Each description included one of five different financial disclosures.
One said the study leader might benefit financially from the study, one said the study leader would be reimbursed only for trial-related expenses, one said the study leader receives extra money from the drug company for activities such as consulting and speaking, one said the study leader holds stock in the drug company, and one said the researcher's institution holds stock in the drug company.
More than two-thirds of the participants said they weren't surprised that the researcher or institution might benefit financially from the clinical trial. Respondents were least surprised to learn that researchers received a per capita payment, and most surprised to learn the researcher owned stock in the drug company.
While 59 percent of respondents said the possibility of financial benefit for the researcher or institution didn't change their trust, 36 percent said their trust was diminished when they read the financial disclosure.
"A disclosure that the researcher received per capita payments was least likely to change respondents' level of trust whereas as disclosure that the researcher held an equity interest was most likely to reduce trust," the study authors wrote.
The study was published online April 2 in the Journal of General Internal Medicine.
"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."
The U.S. National Institutes of Health has more about clinical trials.
Posted: April 2008