DURHAM, N.C. – When enrolling patients in a clinical trial, researchers should disclose relevant financial relationships that might affect a patient's decision about participation, such as owning stock in the company that funds the study, or having a patent on the device being tested.
It's a process many believe builds trust and fulfills a patient's right to know about financial conflicts of interest.
"But patients often don't understand such disclosures and generally don't use the information when deciding what they are going to do," says Kevin Weinfurt, Ph.D., a medical psychologist at Duke University Medical Center and the lead author of a paper published in the August 27 issue of the New England Journal of Medicine. "The public is increasingly demanding transparency, but if our disclosure system isn't accomplishing what we hope it will, then we may need to change it."
Weinfurt, along with Jeremy Sugarman, M.D., professor of bioethics and medicine at the Berman Institute of Bioethics at Johns Hopkins and the senior author of the paper, drew upon a five-year research project examining disclosure policies and practices (the Conflict of Interest Notification Study, or "COINS") and developed the following guidelines for institutions attempting to fully comply with the spirit and intent of disclosure:
"Disclosure alone is not enough," says Sugarman. "It is not the remedy that many seek, although the process may have a positive effect on patients' satisfaction with and trust in the research process."
Weinfurt says patients considering whether to enter a clinical trial have every right to know about financial interests in research, such as doctors owning stock in the company that is paying for the research, or a physician who holds a patent interest in a device that is being studied. But he also argues that patients need to do their homework, too. He says any patient considering enrolling in a clinical trial might want to be prepared to ask these four questions:
The study was funded by a grant from the National Heart, Lung and Blood Institute.
Colleagues who contributed to the study include Kevin Schulman and Joelle Friedman, from Duke; and Mark Hall and Nancy King of Wake Forest University.