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Participation
in clinical trials is urged
(June 2008
Issue)
By Phyllis Hanlon
Kenneth A. Getz, MBA, founder of the non-profit Center for Information
& Study on Clinical Research Participation (CISCRP) and senior research
fellow at the Tufts Center for the Study of Drug Development, knows
firsthand the importance of volunteering for clinical trials.
As an undergraduate psychology major at Brandeis University, he
worked with his professors on a number of clinical trials investigating
interventions for cognitive development, behavioral and memory issues.
The work he does now relates to policy for increasing the safety
and ethical treatment of participants in clinical trials.
In 1995, Getz created a Web site that listed active clinical trials
seeking participants and provided educational materials for professionals.
"By 1997-98, the site saw a lot of traffic from patients looking
for information. They wanted to learn more about the trials and
the risks and benefits of participation," he says. Thus was born
CISCRP, which became an educational/outreach mechanism for the public
and has increased the visibility of clinical trials.
While the goal of the organization is to increase awareness of
the value of participating in clinical trials, CISCRP also strives
to ensure that volunteers know all the risks and benefits involved.
"We try to make sure the decision is as informed as possible. Participants
should know the risks tied to investigational intervention, that
they might cause adverse/serious reactions," Getz says.
Getz reports that more than 20 million individuals respond to inquiries
for trial participants. "Of that number, two million will ultimately
participate and complete a clinical trial," he says. Several factors
influence the high drop out rate, including adverse reactions, too
frequent on-site visits, failure to connect with trial staff and
demands placed on an individual's home life and work schedule. "This
speaks to the reality of being a study participant," says Getz.
Leonard A. Doerfler, Ph.D., director of the counseling psychology
program at Assumption College in Worcester, says that volunteering
for clinical trials often stems from a sense of altruism. "If others
can benefit from what [a participant has] dealt with, they feel
they are making a contribution to the betterment of society," he
says. "Some come at it as a sense of giving and helping others who
experience similar difficulties."
He adds that, since clinical trials investigate a potentially better
intervention than already exists, participants have the opportunity
to receive the latest therapy.
Getz points out that a "robust number of psychologists are conducting
clinical trials under grant-funded programs." Some of these trials
relate to pharmacological interventions involving antidepressants,
antipsychotics and other drugs. Other trials investigate different
diagnostic approaches and behavioral therapies for a variety of
psychiatric conditions.
Although to the general public, there may seem to be a significantly
high number of studies, Doerfler explains that confusion can arise
when one study contradicts another. "Each study can't stand alone,"
he says. "A gradual accumulation of facts leads to changes over
time."
Getz says, "Some people express a passing curiosity [about clinical
trials]. But they don't see how it relates to them. They don't understand
that every medication in their medicine chest involved participation
[in trials] of people like themselves."
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