#Unrealistic optimism. trial#

This time she would participate in one of the earliest studies of a brand-new drug, a Phase I clinical trial, and would have to undergo major surgery before taking the experimental drug.

Nonetheless, when her cancer began growing again, she eagerly applied for a third study. She had endured countless hospitalizations, serious bloating, a punctured lung, overwhelming fatigue and two nearly intractable infections. Her tumor had responded slightly during one of those studies, but slowing the pace of its growth had come at a significant price. By the time I met her, she was already the veteran of two clinical trials at the center. Known for her cheery disposition she reminded the doctors and nurses of a brunette Cathy Rigby she had melanoma that had spread through her body despite efforts to halt its growth. One of the patients was a woman in her late 30s, a mother of three. Every week, patients with rare diseases and cancers that had not responded to standard therapy arrived from all over the country, eager to try something new, even if the efficacy of the treatments had not yet been proven. It will require us to pay more attention to how patient-subjects apply information to themselves and to become more aware of the social-psychological factors that might impair decision-making in this context.As a medical student and later during my residency, I trained for some time in a medical center known for its research and clinical trials. The authors said that unrealistic optimism has the potential to compromise informed consent 'by interfering with the ability to apply information realistically.' They concluded: 'Improving the consent process in oncology research will require us to do more than address deficits in understanding. Misunderstanding the purpose was not significantly related to unrealistic optimism, the study found. 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.

#Unrealistic optimism. trial#

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. Individuals can have one form of optimism without the other.

Unrealistic optimism, which social psychologists define as being specific to a situation and consider a form of bias, is distinct from 'dispositional optimism,' which is a general outlook on life and is neither realistic nor unrealistic. Questionnaires assessed signs of unrealistic optimism, as well as participants' understanding of the trials' purpose. 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. '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. 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.