IRB: Ethics & Human Research

Therapeutic Misperceptions in Early-Phase Cancer Trials: From Categorical to Continuous

Abstract: Appropriate enrollment in early-phase clinical trials demands that potential research participants understand and appreciate critical study-related information, because discrepancies in understanding or appreciation can potentially invalidate informed consent to participate in research. Four terms were previously developed to categorize these discrepancies: therapeutic “misconception,” “therapeutic misestimation,” “therapeutic optimism,” and “unrealistic optimism.” In this article, we propose a continuous framework of therapeutic misperceptions, rather than discrete categorical concepts. One end of this continuum contains discrepancies in understanding, and at the other end are discrepancies in appreciation. Categorical terminologies represent points along this continuum. Discrepancies in understanding and appreciation each lead to unique ethical concerns and likely require different interventions. This framework highlights the dearth of empirical work on the appreciation end of the continuum, especially related to navigating persistent discrepancies in appreciation. Employing a continuous framework of therapeutic misperceptions supports a nuanced approach to the unique circumstances of each research subject, aiding researchers in supporting truly informed consent.

Keywords: human subjects research, early phase clinical trials, cancer clinical trials, informed consent, therapeutic misconception, therapeutic misestimation, therapeutic optimism, unrealistic optimism

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