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Unrealistic optimism created ethical dilemma in early-phase cancer trials
Jansen L. IRB: Ethics & Human Research. 2011;33:1-8.
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The unrealistic optimism of patients participating in early-phase clinical oncology trials may bias their informed consent, researchers at The Hastings Center found.
Researchers enrolled 72 patients, aged 18 years and older, who were involved in phase 1, phase 1/2 or phase 2 clinical cancer trials at major New York City metropolitan comprehensive cancer centers from August 2008 to October 2009. Participants were asked five questions that compared their own odds of benefiting from their respective trials to those of others enrolled in the same trial. Participants were also asked about their understanding of the trials in which they were engaged.
Unrealistic optimism was defined as the optimism experienced toward specific events or hazards; dispositional optimism was defined as having an optimistic outlook on life in general.
Results indicated that patients exhibited an optimistic bias in response to the possibility of their cancer being controlled by their trial’s drug (P<.050), experiencing health benefits from participating in the trial (P<.001), and not experiencing adverse affects from their trial’s drugs (P<,.050). Researchers found no patients had significant optimistic bias as to whether standard or trial drugs would cure their cancer.
Most participants (72.9%) reported that the purpose of their oncology trial was to advance generalizable knowledge with the potential to benefit future patients. Roughly one-fourth of the participants reported their respective trial had another purpose. The 2.9% of respondents who reported a combination of purposes were dropped from the trial.
“We found no significant relationship between unrealistic optimism scores and misunderstanding about the purpose of these trials,” researchers wrote. “As a bias, unrealistic optimism may or may not be accompanied by a hopeful state of mind. But since it is a bias, unrealistic optimism has the potential to compromise the informed consent of participants in clinical trials.”
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