new YORK (Reuters Health) – the participant of
clinical trials phase I Oncology therapies
they language the risks and the possible sobreestimarÃan
benefits, suggests a study.
These tests are often the first time that a new drug
tested in humans and its aim is to assess the effects
adverse and acceptable doses. Participate in these studies
rarely is good for the health of the patient.
“Note that the Act to understand what it’s all about the
“”
participation is much more complicated than you think”, said the
principal author, Rebecca Pentz, Professor of ethics of the
research of the Faculty of medicine at Emory University,
Atlanta.
Pentz said 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.
Pentz team interviewed 95 patients in a trial
phase I cancer clinical. To determine if they blended
research with care, the authors asked them
If the trial aimed to help science or they like
patients, and if 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 risk.
While 89 participants rated “high” with its
level of optimism, 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
“
get worse and that, 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 the progress in the
past 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 to be of a single centre and mainly include
patients with high income and white.
Furthermore, Christine Grady, Director of the Department of
Bioethics Center 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
“”
are General”, said Grady.
Source: Cancer, online January 13, 2012.
