(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.
(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. This is the so-called therapeutic misconception. (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 reality has given rise to much ethical concern. 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. Early-phase oncology trials are vital for developing new and more effective therapies for treating cancers.