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

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Clinical Trial Coordinators Need More Financial Conflict-of-interest

Training

http://www.medicalnewstoday.com/medicalnews.php?newsid=68635

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 s 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 le Friedman, who

presented the results of the latest survey during the annual meeting

of the Association of Clinical Research Professionals in Seattle.

Sugarman, M.D., of s 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, s 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, " 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.