The debate over informed consent in early-phase clinical cancer trials rages on, says clinician Pauline Chen in a New York Times health column. Research on patients' motivations for signing up for such trials — which typically test only for toxicity and dosing, not therapeutic efficacy — indicate that despite explanations by researchers, they may never really understand the purpose of the trial. This, Chen says, could be as a result of cancer patients' need to be optimistic and "express hope." Until now, researchers have assumed that such optimism poses few ethical concerns. But that assumption is now being challenged — researchers at the Hastings Center have published a study showing that cancer patients can be blinded to the realism of their disease. The researchers surveyed 70 patients enrolled in early-stage trials and asked them about their expectations. Though the majority understood the purpose of the trial, "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," Chen says. "A majority of patients assumed that the experimental drugs would control their cancer and that they would experience benefits but not complications." Such optimism in clinical trials is worrying from an ethical point of view, and the bias is hard to combat because patients aren't always aware that it exists.
On the Bright Side
Mar 10, 2011