It is a bedrock of medical ethics that patients may participate in clinical trials only if they give informed consent. This means that patients must get information about the trial, demonstrate that they understand that information, have the mental capacity to make a decision about becoming a research participant and make that decision voluntarily.
But a group of bioethicists, behavioral researchers and physicians are questioning whether “unrealistic optimism” may undermine a patient’s ability to give informed consent.
Having a generally optimistic outlook on life, even when you’re fighting cancer, isn’t a problem for medical research. But unrealistic optimism comes into play when a patient believes he or she is more likely to benefit from a treatment – or less likely to suffer a side effect – than other patients in the same situation. The bias that results from unrealistic optimism could skew a patient’s understanding of the potential risks and benefits of enrolling in a trial.
To find out, the research team sent questionnaires to 72 patients with blood, breast or lung cancers or myelodysplastic syndrome (formerly known as pre-leukemia) who were already enrolled in an early-phase cancer trial. On the whole, the patients realized their cancers were not likely to be cured (either with existing drugs or experimental ones).