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Last Updated: Oct 6, 2008 - 12:00:27 PM |
WEDNESDAY April 2, 2008 (Foodconsumer.org) -- Patients are willing to participate in a clinical trial even if knowing a researcher's financial interest in the study unless the amount of money a researcher to earn depends on the results of the trial, a new study found.
The study was funded by the National Heart, Lung and Blood Institute, conducted by researchers at the Duke Clinical Research Institute (DCRI), Wake Forest University, and the Johns Hopkins Berman Institute of Bioethics, and published in the April 2, 2008 online edition of the Journal of General Internal Medicine.
"We found that the patients we surveyed rated most types of financial disclosures less important in influencing their decisions to participate than other factors, like the risks and benefits of the proposed treatment," said Kevin Weinfurt, Ph.D., deputy director of the DCRI's Center for Clinical and Genetic Economics, and lead investigator on the study.
"We also found that some patients are savvy enough to distinguish between different types of financial relationships, and they have different reactions based on these distinctions."
In the study, the researchers asked each of more than 3,600 diabetes and asthma patients to answer questions related to their willingness to participate in a hypothetical clinical trial. Each survey contained one of five financial disclosure statements.
"The disclosure statements ranged from the generic -- the doctor running the trial might benefit financially from the study -- to the more specific -- dealing with per capita payments, and ownership of equity on the part of the researcher or the institution," Weinfurt said.
"We found that none of the disclosures significantly affected subjects' willingness to participate with the exception of ownership of equity on the part of the researcher."
Thirty percent said they would not take part in the clinical trial when told the trial leader could gain or lose money deepening on the outcome of the study, compared to 25 percent when presented with a generic disclosure -the doctor running the trial might benefit financially from the study, and 20 percent when told the investigator received payments from industry to cover the cost of running the study.
"It's likely that patients felt ownership of equity could influence the researcher's behavior in the trial, which might jeopardize the patients’ rights and welfare," he said.
The researchers found participants' willingness to participate in a clinical trial does not mean they trust the researcher or the institution.
"It is essential that clinical research is a trustworthy endeavor, so we need to think carefully about the implications of these findings," said Jeremy Sugarman, M.D., a professor of bioethics and medicine at the Johns Hopkins Berman Institute of Bioethics and senior author of the study.
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