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
"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.
Source : Duke University Medical Center