Clinical Trial Coordinators Need More Financial Conflict-of-interest Training

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.

"That more than three-quarters of the coordinators did not feel that they had enough information about possible financial conflicts of interest is high," Kevin Weinfurt, Ph.D., deputy director of the Center for Clinical and Genetic Economics at the Duke Clinical Research Institute said. "It is the responsibility of the clinical trial's principal investigator to ensure the coordinators are thoroughly educated on all aspects of the trial."

Of those coordinators who said they were uncomfortable answering questions about financial interests, 58 percent said it was because of a lack of knowledge. The researchers also found that 13 percent of the coordinators who felt uncomfortable disclosing financial information thought that the information was a private matter for the investigator.

"These findings are important because they underscore the importance of on-the-job experience and how coordinators new to their positions might benefit from additional education and training," Weinfurt said.

The researchers surveyed 300 coordinators who were attending the 2006 international conference of the Association of Clinical Research Professionals. The full report of this study will be published soon in the journal Clinical Trials.

Earlier COINS projects have looked at official institutional policies involving conflicts of interest in research and how potential study participants view these conflicts, as well as the reluctance of some researchers and officials to disclose financial interests to potential participants in the trials.