Unrealistic Optimism in Early-Phase Cancer Trials: Ethical Implications

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When Optimism Is Unrealistic
“But despite clearly understanding the purpose, and limits, of early-phase (Drug) trials, the patients were also blinded by what researchers called an unrealistic optimism, or an optimistic bias, when it came to applying that knowledge to their own particular situations. A majority of patients assumed that the experimental drugs would control their cancer and that they would experience benefits but not complications. In essence, they believed they would fare better than the average patient enrolled in the same trial.”

When Optimism Is Unrealistic” discusses the ethics of informed consent in early-phase clinical trials that test only toxicity and dosing and offer little therapeutic benefit to the patients enrolled. Researchers have debated for decades the motivations of patients who participate in such trials, with some research suggesting that patients may never fully understand the purpose of the trials. Others have suggested that patients are driven by altruism and a desire to help others who may one day suffer from the same disease. More recent studies suggest that patients may simply be optimistic and have strong needs to express hope. However, a group of ethicists has published a study challenging this assumption. The researchers surveyed 70 patients enrolled in several early-phase cancer trials and found that the patients had an unrealistic optimism bias, believing that the experimental drugs would control their cancer and that they would experience benefits but not complications. In essence, they believed they would fare better than the average patient enrolled in the same trial. The researchers argue that such unrealistic optimism poses ethical issues when placed in the context of early-phase clinical cancer trials.

The article concludes by stating that distinguishing between different kinds of optimism is necessary. The article highlights that unrealistic optimism is different from dispositional optimism, which refers to a general optimistic outlook. The study suggests that unrealistic optimism is part of human psychology and that even patients who have a generally optimistic outlook are not immune to such biases. The article highlights that unrealistic optimism in early-phase clinical cancer trials results in a perfect ethical storm, and understanding different types of optimism is crucial in distinguishing ethical issues.

When Optimism Is Unrealistic, Pauline W. Chen, M.D., New York Times

https://www.nytimes.com/2011/03/03/health/views/03chen.html Unfortunately, access requires a login or subscription.