People enrolled in phase I clinical trials often equate medical research with medical care and misjudge the risks and potential benefits of participating in a trial, according to a study by researchers at the Emory University School of Medicine in Atlanta, GA (Cancer published online 2012 Jan 31). Suggesting a need for more straightforward consent forms, the study also “shows that the picture of understanding is much more complex than we thought,” says lead investigator and research ethics professor Rebecca D. Pentz, PhD.
Pentz and her team asked 95 patients in phase I clinical trials of cancer therapies 2 questions about the purpose of the trial: Is the research study mostly intending to help research and gain knowledge or mostly intending to help you as a person, and does the research study or your physician decide the treatments?
Just 31 participants correctly answered both questions.
Participants were also asked why they enrolled in the study, what benefits they hoped to gain, what the study's risks were, and whether any risks were of special concern. Additionally, they estimated their probable benefits and risks.
Nearly all—89 of 95—incorrectly estimated the risk and chance of benefit of joining a phase I trial, with 13 respondents asserting that there were no risks. Fifty-nine people estimated that they had at least a 70% chance of personal benefit. However, the investigators did not conclude that these misestimates demonstrated a high level of misunderstanding, because most participants explained that their estimates of benefit were not intended to be statements of fact, but rather what they hoped would happen.
Participants almost never listed the risks from the extra procedures that are part of research—blood draws every half hour, for example. “They just didn't focus on what is unique to research,” explains Pentz. “Physicians have to hammer home that research isn't just me taking care of you.”
But the most surprising finding, Pentz says, was the significant number of patients who estimated their personal benefit as lower or their personal risk as higher than that of the rest of the population. “I did not anticipate that,” she adds. “The phase I picture is psychologically complex.”
Although current consent forms explain how a clinical trial will differ from standard care, the details are generally woven throughout the document. Clinical trial subjects might have a better understanding of the trial's intent, as well as the risks and potential benefits of participating, if the information was presented in a tear-out chart, says Pentz. Her team's next study will assess the effectiveness of just such a form.
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