Financial Toxicity in Early Phase Oncology Clinical Trials: A Review and Ethical Analysis.

Of the many burdens cancer patients face, the impact on personal finances is often invisible to clinicians. Financial toxicity refers to the negative impact on patients' and families' quality of life due to a combination of high out-of-pocket costs of medical treatment, diminished savings, and psychological distress as a result of diminished finances. Financial toxicity in cancer care has been more closely examined in the standard-of-care setting. Financial toxicity in the early phase clinical trial setting, and the ethical implications of making patients pay out of pocket to access experimental interventions that may not have therapeutic benefit, have yet to be explored. This article seeks to highlight hidden costs of clinical trial participation in the U.S., and to illustrate how patients are susceptible to financial toxicity from nonmedical direct costs and indirect costs even though a trial intervention itself is not charged to the patient. We argue that not informing prospective participants of the potential costs of trial participation threatens their autonomy and interferes with researchers' prima facie duties to beneficence and nonmaleficence.