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The Ethics of Phase 0 Oncology Trials

Authors' Affiliations: ¹ Department of Bioethics, NIH Clinical Center, Bethesda Maryland; and ² Berman Institute of Bioethics, Johns Hopkins University, Baltimore, Maryland

Requests for reprints: David Wendler, Department of Bioethics, NIH Clinical Center, Building 10, Room 1C118, Bethesda, MD 20892-1156. Phone: 301-496-2429; Fax: 301-496-0760; E-mail: dwendler{at}nih.gov.

Abstract

Recent guidance from the Food and Drug Administration supports the conduct of a new type of exploratory clinical trial, commonly called phase 0 clinical trials. Proponents argue that phase 0 clinical trials have the potential to expedite the development of new oncology drugs while exposing fewer research subjects to the risks of experimental treatments. At the same time, phase 0 oncology trials raise important ethical concerns that have received little attention. In particular, there is a question of whether it is ethical to enroll individuals in research that offers them no potential for clinical benefit. Further concern focuses on the inclusion of terminally ill and consequently vulnerable cancer patients in these trials. To evaluate these concerns, this article considers relevant empirical data from phase 1 oncology trials and develops several recommendations regarding the conduct of phase 0 clinical trials in oncology.

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