Truth and Consequences and Enrollment in Clinical Trials

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 Dr. Kevin Weinfurt, a medical psychologist at Duke and the lead author of the study.

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

The findings, appearing 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.

Researchers from Duke University Medical Center, Johns Hopkins Berman Institute of Bioethics and Wake Forest University conducted 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 first 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 also spontaneously offered three times the number of negative comments about the relationship than participants in the other groups, using words like, "disingenuous," "unacceptable," and "unethical." Ten members of this group also spontaneously said they would not take part in a trial where the lead investigator held stock in the company sponsoring the trial.

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, saying, "OK, that sounds more appropriate. So there's no payment to him, but through the university. OK, I'm good."

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, M.D., Harvey M. Meyerhoff Professor of Bioethics and Medicine at the Johns Hopkins Berman Institute of Bioethics and senior author of the study, who says the research offers implications for health care policy. "Policy makers may want to consider more restrictive policies for equity relationships than for other financial interests in research."

The study was funded by a grant from the National Heart, Lung, and Blood Institute.

Other researchers from Duke who were involved in the study include Joelle Friedman, Chantelle Hardy, Alice Fortune-Greely, Janice Lawlor, Jennifer Allsbrook, Li Lin and Kevin Schulman. Mark Hall, from Wake Forest University, also contributed to the study.

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