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MONDAY, Aug. 4, 2003 (HealthDayNews) -- Some people are overly optimistic about the benefits they'll experience when they take part in a Phase I clinical trial, says a study led by Duke University Medical Center.
The study looked at how that optimism and other personality traits may influence a person's decision to take part in a clinical trial. Understanding that factor could help researchers identify problematic areas in the informed consent process of medical trials.
"Many patients operate under what has been called a 'therapeutic misconception' that Phase I clinical trials are designed to provide them with personal benefit," lead author Kevin Weinfurt, deputy director of the Center for Clinical and Genetic Economics at Duke, says in a statement.
"We are trying to understand how, even with extensive counseling, patients continue to express high expectations. Once we know what's behind these statements, perhaps we can address them in the consent process," he adds.
Phase I clinical trials are designed primarily to determine the safety of a treatment, rather than to test its clinical benefit. A key element of informed consent for people taking part in clinical trials is a proper understanding of the treatment or trial.
People with high expectations that they'll gain some benefit from a Phase I clinical trial may not appreciate the true purpose or potential risks of the trial.
In the study, researchers surveyed 260 cancer patients enrolling in Phase I clinical trials. All of them had advanced cancer that had failed to respond to standard therapy or for which there was no standard therapy.
The patients were asked about their expectations that their cancer would be controlled by the experimental therapy studied in the trial.
Patients were more likely to have a high expectation of clinical benefit if they reported better health-related quality of life, stronger religious faith, greater optimism, a willingness to take monetary risks, and had a slightly poorer understanding of a statistical statement about the chance of benefit offered by the clinical trial.
Nearly 25 percent of all the patients surveyed said they believed they had a 50 percent chance of the therapy working for them. That's about 10 times more than the actual probability of 5 percent.
"We were also surprised to find that patients who reported high expectations that they would receive clinical benefit from the trial also had high expectations of the level of benefit. These patients believed the chance of benefit was high, and that the maximum type of benefit they could experience would be very dramatic," Weinfurt says.
The study appears in a recent issue of the journal Cancer.
More information
Here's where you can learn more about clinical trials.
