Unrealistic Optimism Common in Early Clinical Trials

[Guest guest]

I would submit that patients must get something out of their participation in a

trial; even if that possibility is as remote as expanding the field of knowledge

of their cancer, so that they may benefit down the road.

Since I'm on my fifth trial, I will admit that some personal benefit is always

in the back of my mind. Oh, and the fact that CLL is incurable and everyone

always relapses. Hence, an urgent need for new agents.

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Unrealistic Optimism Appears Common in Early Cancer Trials

Study suggests it may compromise informed consent

(Garrison, NY) Can optimism be ethically problematic? Yes, according to a new

study, which found unrealistic optimism prevalent among participants in

early-phase cancer trials and suggested that it may compromise informed consent.

Many cancer researchers and ethicists assume that hope and optimism in the

research context are " always ethically benign, without considering the

possibility that they reflect a bias, " write the authors of the study, which

appears in IRB: Ethics & Human Research. " Others have claimed that unrealistic

expectations for benefit are a result of misunderstanding and that the proper

response to them is to provide patient-subjects with more information… " But the

study cast doubt on both assumptions.

The study included 72 patients with cancer who were enrolled in early-phase

oncology trials in the New York metropolitan area between August 2008 and

October 2009...

Study respondents exhibited unrealistic optimism in response to three of five

questions about the likelihood of particular events happening to them compared

with other trial participants: having their cancer controlled by drugs

administered in the trials, experiencing a health benefit from the drugs in the

trials, and not experiencing a health problem from the drugs in the trials.

However, a substantial majority of the respondents – 72 percent – accurately

understood that the purpose of the trials was to advance knowledge with the

potential to benefit future patients and not necessarily to benefit them.

Misunderstanding the purpose was not significantly related to unrealistic

optimism, the study found.

The authors said that unrealistic optimism has the potential to compromise

informed consent " by interfering with the ability to apply information

realistically. "

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