A critical component of informed consent is an understanding of the potential risks and benefits of investigational treatments. In the context of early-phase oncology trials, concern has been raised about whether this understanding is adequate, since patients tend to express high expectations about their treatment outcomes.
Our group has sought to obtain empirical data about what patients actually intend when they state an expectation of benefit that exceeds historical results and their own physicians’ estimations. Whereas some medical ethicists have argued that such expressions represent a failure of the consent process, we have found that when patients are asked, “What is the chance you will benefit?” they are not necessarily providing a population frequency estimate with their response. What, then, are patients expressing, and is this a problem?
There is substantial normative pressure for patients with cancer to be “optimistic,” yet little is known about whether such attitudes are beneficial (or harmful) in the setting of early-phase clinical trials, where a poor disease outcome is common. We are hoping to answer this question through longitudinal study of psychological outcomes among patients taking part in early-phase trials.
The informed consent process in oncology is characterized by a high level of uncertainty regarding harms and benefits, and hence requires a particularly sensitive approach by clinical researchers who wish to ensure understanding but avoid dashing hope. What is too much optimism? The answer requires attention not only to what patients “know,” but also what they “mean.” ■
Disclosure: Dr. Meropol reported no potential conflicts of interest. He is coauthor of the article by Weinfurt KP et al,4 cited in the accompanying article.
Dr. Meropol is Chief, Division of Hematology and Oncology, University Hospitals Seidman Cancer Center, Case Western Reserve University, and Associate Director for Clinical Research, Case Comprehensive Cancer Center, Cleveland, Ohio.
It has been found that many patients in early-phase oncology trials believe their chance of benefit to be much higher than estimates derived from historical data.1-3 In a recently reported study in Journal of Clinical Oncology, Kevin P. Weinfurt, PhD, of Duke Clinical Research Institute, and...
Our work suggests three specific recommendations for researchers and care providers who are discussing with patients the possibility of enrolling in a phase I clinical trial.
First, we should always communicate the likelihood of benefit in terms of the number of participants expected to derive...