Ethical Trials

November 30, 2008

Knowing about financial relationships between medical researchers and the companies that sponsor their studies has little effect on most patients considering enrolling in a clinical trial, according to a new study from the Duke Clinical Research Institute.

"The patients in our study were very clear: They told us they care about these relationships and want to be fully informed about them. But at the same time, the information didn't substantially affect their decision to enter a trial," says Kevin Weinfurt, associate professor of medical psychology and the lead author of the study.

What seemed to be more important in the decision-making process was the patients' level of trust in medical research in general, Weinfurt says.

The findings, which appear online in American Heart Journal, reveal that patients are astute enough to draw distinctions between various types of financial arrangements, finding some reasonable, and others less so.

The study, funded by a grant from the National Heart, Lung, and Blood Institute, was based on a telephone survey of 470 patients diagnosed with coronary artery disease who agreed to go through a consent process involving enrollment in a hypothetical clinical trial.

Investigators assessed the patients' overall level of trust in medical research through a four-item questionnaire and then randomized them into one of three disclosure groups. Patients who were told that the doctor leading the study also held stock in the company sponsoring the research were the least willing to participate in the study. They offered three times the number of negative comments about the relationship than participants in the other groups.

Patients who were told that the sponsoring company covered the cost of the trial, including the physician's salary, were generally accepting of such a financial relationship.

Participants in the study were disproportionately middle- to higher-income white men, and the researchers say lower-income participants from other racial groups might feel differently about financial relationships between researchers and sponsoring companies.

"We clearly live in a time of heightened sensitivity about these matters," says Jeremy Sugarman '82, M.D. '86, a professor of bioethics and medicine at the Johns Hopkins University's Berman Institute of Bioethics and senior author of the study.

"Policymakers may want to consider more restrictive policies for equity relationships than for other financial interests in research."