Academic journal article IRB: Ethics & Human Research

Unrealistic Optimism in Early-Phase Oncology Trials

Academic journal article IRB: Ethics & Human Research

Unrealistic Optimism in Early-Phase Oncology Trials

Article excerpt

Early-phase oncology trials are vital for developing new and more effective therapies for treating cancers. While it is possible that some of these trials provide benefit to patient-subjects, (1) it is widely recognized that early-phase trials are not designed to provide direct therapeutic benefit to those who participate in them. This reality has given rise to much ethical concern. (2) Why would patients agree to enroll in clinical trials that expose them to treatment interventions that offer relatively little prospect for direct therapeutic benefit? One possibility, much discussed over the past two decades, is that many patients fail to understand the nature and purpose of the research in which they agree to participate. This is the so-called therapeutic misconception. (3) Another often mentioned possibility is that patients enroll in early-phase cancer trials because they genuinely want to help researchers obtain scientific knowledge that might benefit future patients who suffer from the same disease. (4) A third range of possibilities recently has begun to receive more attention: expectations for benefit from early-phase oncology trials may simply reflect the fact that patients are hopeful or optimistic about their participation in these trials. (5) It remains unclear, however, what accounts for this optimism. Do optimistic expectations for benefit just reflect a disposition to think positively in difficult situations, or is something more going on? We investigated the possibility that optimistic expectations for benefit are tied to a bias that distorts, or has the potential to distort, how patients process information about the potential risks and benefits of clinical trials.

Our findings raise questions about a common assumption that many cancer researchers have about optimism. This assumption is the view that optimism presents no ethical problem for informed consent to participate in cancer research. (6) It is sometimes claimed further that expressing optimism in the context of cancer research is a good thing. (7) Indeed, it has been suggested that optimism is an effective means for patient-subjects to cope with anxiety or ward off depression. (8) Yet as research in social psychology has revealed, optimism is a complex phenomenon. While it may reflect mere hopefulness and it may provide some psychological benefits, optimism may also be the product of a bias in which a person believes that she is more likely to experience positive outcomes (or less likely to experience negative outcomes) than others similarly situated. When optimism is the product of a bias of this kind, it is typically referred to as the "optimistic bias" or "unrealistic optimism." In the context of early-phase oncology research, unrealistic optimism may have negative consequences for behavior, and it may present an ethical problem for informed consent in clinical research. (9)

The Concept of Unrealistic Optimism

Unrealistic optimism, understood as a bias, has been extensively studied in social psychology. The optimistic bias has been found to be present in a wide range of health-related contexts in which people are presented with risks and benefits. (10) However, since the notion of unrealistic optimism may be unfamiliar to some readers, we now provide some background to the phenomenon.

Unrealistic optimism should not be equated with optimistic attitudes per se. Not everyone who is optimistic is unrealistically optimistic. Some people have a general positive outlook on life. This kind of optimism is often referred to as dispositional optimism. Since it refers to a general orientation, it is neither realistic nor unrealistic. (11) In contrast, unrealistic optimism is present with respect to specific events or hazards. A person can be unrealistically optimistic about some event without being dispositionally optimistic, and vice versa. With respect to a specific event, it is also possible for a person to believe accurately that he is more likely to experience a positive outcome or less likely to experience a negative outcome than similarly situated others. …

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