A patient's willingness to participate in a clinical trial may be unaffected by the disclosure of a researcher's financial interests in the study, unless the amount of money a researcher stands to earn depends on the results of the trial, according to a new study by researchers at the Duke Clinical Research Institute (DCRI), Wake Forest University, and the Johns Hopkins Berman Institute of Bioethics.
"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."
More than 3,600 diabetes and asthma patients were surveyed for this study, and the researchers asked each to answer questions related to their willingness to participate in a hypothetical clinical trial. Each electronic 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."
This disclosure stated that the study leader could gain or lose money depending on the outcome of the study, Weinfurt said. Nearly 30 percent of respondents presented with this disclosure were unwilling to participate in the trial, as compared to 25 percent of respondents presented with a generic disclosure, and 20 percent of those who were 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.
In addition to their willingness to participate in the trial, the subjects' reactions to the financial disclosures were also assessed as they related to level of surprise, confidence in the quality of the science, and trust of the researcher and the institution.
"Interestingly, we found that trust seemed to be the most affected, although it didn't necessarily correlate with their willingness to participate," Weinfurt said. "One-third of the respondents said the financial disclosures made them less trusting of the researcher or the institution, but further studies will be needed to really tease out the implications of this."
"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.
The relationships between researchers and industry are becoming more complex, Weinfurt said, leading to greater interest and visibility for this issue as it relates to patients.
"The Department of Health and Human Services, among other organizations, has issued a call to the scientific and medical communities to consider whether disclosing financial relationships between investigators and industry during the consent process would help protect the rights and welfare of patients. Our data can help answer this question," Weinfurt said. This study is one of several projects conducted as part of the Conflict of Interest Notification Study (COINS), led by Sugarman.
The researchers published their findings in the April 2, 2008 online edition of the Journal of General Internal Medicine. The study was funded by the National Heart, Lung and Blood Institute.
Other researchers involved in this study were Michaela Dinan, Venita DePuy, Joelle Friedman and Jennifer Allsbrook of Duke; and Mark Hall of Wake Forest University.
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