Medical professionals conducting clinical trials should provide more information about financial conflicts of interest before they talk to patients about participating in the trials.
That is one of the main conclusions of a new survey by researchers from Duke University Medical Center and Johns Hopkins University. Their study found that 41 percent of the clinical trial coordinators surveyed had experience disclosing financial aspects of the trial to potential participants, and 28 percent of the coordinators had been asked by participants about potential financial conflicts.
Financial interests can include such things as corporate support for the costs of the trial and its personnel, a researcher's consulting contract with a company that has a vested interest in a trial and an investigator's ownership of stock in a sponsoring company. Clinical trial coordinators usually conduct most of the informed consent process by explaining to potential participants such details of the study as possible health benefits and risks. But more frequently now, the talk also includes financial conflicts of interest when they are relevant to the particular trial.
"We found that coordinators who had more experience discussing financial matters felt more comfortable in discussing them with potential clinical trial participants," said Joelle Friedman, who presented the results of the latest survey April 22, 2007, during the annual meeting of the Association of Clinical Research Professionals in Seattle. Jeremy Sugarman, M.D., of Johns Hopkins Berman Institute of Bioethics, also participated in the presentation.
"When we asked the coordinators what they felt were the major barriers to providing financial information to patients, 76 percent cited lack of information about the financial aspects of the trial and 26 percent said they didn't think the patient would understand the disclosure," Friedman continued.
The survey was part of the ongoing Conflict of Interest Notification Study (COINS), a five-year, $3 million project funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health. The study is a collaboration among Duke University Medical Center, Johns Hopkins and Wake Forest University. The goal of the project is to analyze all aspects of financial disclosure to potential research participants and provide data and recommendations to help medical institutions and government agencies develop guidelines for such disclosures.