Clinical Trial Volunteers Mostly Indifferent - But Not Blind to - Researchers' Financial Conflicts - 04/08/2008
Clinical Trial Volunteers Mostly Indifferent - But Not Blind to - Researchers' Financial Conflicts
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 peoples’ 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 peoples’ attitudes and trust in clinical research,” says Jeremy Sugarman, M.D., M.P.H., M.A., professor at the Johns Hopkins Berman Institute of Bioethics and The Johns Hopkins School of Medicine.
“We need to keep this in mind as we determine how best to disclose acceptable financial interests to fully inform potential study participants.”
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 drug’s maker.
“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 says. “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 University School of Medicine and Wake Forest 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 of the respondents indicated that the financial disclosure was less important to their decision about participating than such factors as potential risks and benefits, and the purpose of the research.
In the computerized experiment, the investigators electronically sent each patient a description of a hypothetical clinical trial to test a drug that might treat their particular condition. The recipients were grouped by the severity of their illnesses.
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 company.
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 of the study respondents 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 the severity of the disease.
“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 policymakers involved in clinical trials should probably pay close attention to the impact of financial disclosures on potential study subjects.
Other researchers who participated in the study include Kevin P. Weinfurt, Michaela A. Dinan, Venita DePuy, Joelle Y. Friedman, Jennifer S. Allsbrook, all from Duke University School of Medicine, and Mark A. Hall from Wake Forest University Schools of Medicine and Law.
The study was funded by a grant from the U.S. National Heart, Lung, and Blood Institute to Dr. Sugarman.
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