NEW YORK (Reuters Health) - People enrolled in early stage trials for possible cancer treatments may underestimate the risks involved and overestimate the potential benefits, suggests a new study.
The early trials, known as “Phase 1,” are often the first time a new drug is given to humans and the goal of the studies is to test for side effects and acceptable dosage levels. Participation rarely benefits the person’s health.
One of the new report’s authors says it’s well known that people taking part in early trials confuse the research for medical care, but it goes beyond that.
“What we found was that the picture of understanding is much more complicated than once thought,” said Rebecca Pentz, a research ethics professor at Emory University’s School of Medicine in Atlanta who led the study.
Pentz told Reuters Health in an email that when participants describe the risks and benefits of participating in the trial, they may use their descriptions to stay hopeful. She added that they also may not understand that participating in research comes with its own risks, including extra biopsies.
For their study, the researchers interviewed and surveyed 95 patients in a Phase 1 cancer trial.
To find out if they were confusing the research for medical care, the researchers asked whether the trial was meant to help research or them as a person, and whether the study or their own physician decides what the treatments will be.
Only 31 people correctly said that the aim of the study was to benefit research and that the study decided the treatment.
Some believe the misconception may stem from early trial participants -- who may have tried medications that failed, or have a rare illness for which the study drug is targeted -- having few treatment options, but the researchers did not find this to be the case.
As to whether participants overestimated the trial’s benefits or underestimated its risks, the researchers found that 59 people said they had a 70 percent or better chance of having some sort of personal benefit. That same number of people estimated their risk to be 30 percent or less.
The researchers said 89 people misestimated the risks and benefits.
A popular theory is that a person’s optimism may cloud their judgment when evaluating what risks are involved.
While 89 people ranked their optimism level as “high,” and the authors say that may support the claim, Pentz says she was surprised to find 29 people estimated their personal benefit to be lower or their personal risk to be higher than the rest of the group. They were pessimists.
“We know that many research trial participants are optimistic that they will do better than most people on trial. But we found a significant minority who expected to do worse but still participated in the trial. We don’t have an explanation for this,” Pentz told Reuters Health.
Overall, the authors write in the journal Cancer, their results show participants still confuse the research for treatment and don’t understand how the two differ, despite advancements made in the last decade.
Mary Faith Marshall, a professor of bioethics at the University of Minnesota in Minneapolis, said despite the study’s limitations -- which include being from a single center and surveying a predominately white and affluent group -- the results are consistent with past research.
“We’ve known for a long time that this problem exists and that there are ways to improve the informed consent process that would get at some of these problems,” said Marshall, who was not involved with the new study.
Marshall said researchers can make sure participants know the trial’s intent and risks by quizzing them and avoiding language that would suggest that there are benefits.
For example, Marshall said sometimes the forms people fill out before a trial use the word “patient,” instead of something like “research participant.”
“When you see the word patient you’re going to think ‘therapeutic.’ Why wouldn’t you?” Marshall told Reuters Health.
Christine Grady, acting chief of the Department of Bioethics at the National Institutes of Health Clinical Center said federally funded research and research that will eventually be vetted by the U.S. Food and Drug Administration must meet certain requirements regarding consent.
“The regulations are not specific to Phase 1 studies. They’re generic,” Grady told Reuters Health.
She added that regulations include such things as the fact that the trial is voluntary, what the expectations are, the risks and benefits and who to contact for more information.
In fact, the National Cancer Institute, which provided funding for Pentz’s study, has a consent form template available on the agency’s website.
But Marshall said it’s understandable that people can be confused, especially if they’re suffering from cancer or in other stressful situations.
“If you have a diagnosis of cancer it’s a hugely stressful time. Even when investigators and their staff do the best job, we forget things,” said Marshall.
SOURCE: bit.ly/zBXLvn Cancer, online January 31, 2012.