new YORK (Reuters Health) – the participants of
clinical trials phase I Oncology therapies
they language the risks and the possible sobreestimarÃan
benefits, suggests a study.
These tests tend to be the first time that a new drug
tested in humans and its objective is to assess the effects
adverse and acceptable doses. Participate in these studies
rarely is good for the health of the patients.
“Note that the Act of understanding of what it is the
“”
participation is much more complicated than you think”, said the
lead author, Rebecca Pentz, Professor of ethics of the
research of the Faculty of medicine at Emory University
Atlanta.
Pentz added by e-mail that when participants
describes the risks and the benefits of participating in a
clinical trial, would use this story to follow hopeful.
But they would not understand if such participation also has
risks, such as the realization of more biopsies.
The team of Pentz interviewed 95 patients of an essay
phase I cancer clinical. To determine if they blended
research with care, the authors asked them
whether the trial aimed to help the science or they
patients, and whether it was the essay or the doctor who “decided” what
treatment be used.
Only 31 participants responded correctly to the
objective of the trial was purely scientific, and that the design of the
study determined the treatment used.
On if the participants sobreestimaban the
benefits of the trial or has its risks, 59 patients
replied that they had a 70 percent or more possibility of
get some personal benefit. That same amount believed a
30 percent or less of risks.
While 89 participants rated “high” with its
level of optimism to Pentz surprised him that 29 people
Express lower levels of optimism or a higher level of
personal risk than the rest of the group. They were pessimistic.
“Detected a significant minority who said that he was going to
“
worse and, even so, still in participating in the trial. “This
can not explain”, said Pentz.
For the team, the results show that the
participants still confuse treatment research and
do not understand the differences despite advances in the
decade.
Mary Faith Marshall, Professor of bioethics at the University
of Minnesota, Minneapolis, considered that the results
are consistent with previous studies in spite of their limitations, as
the fact be de un solo centro and mainly include
white patients with high income.
Furthermore, Christine Grady, Director of the Department of
Bioethics of the Centre for clinical research of institutes
National health, announced that the studies to be carried out
with federal funding and research that can veto the
Food and medicines of United States Administration
must meet certain requirements related with the
informed consent.
“Standards are not only for phase I trials, but that
“”
are General”, said Grady.
Source: Cancer, online January 13, 2012.
