End-of-life care for terminally ill participants in clinical research

Efforts to improve end-of-life care in the United States have paid little attention to the unique concerns of participants in clinical research who are terminally ill. In this paper we focus attention on and offer an analysis of how to meet the needs of these individuals. To address their concerns, we consider how to reconcile two important tasks: providing optimal end-of-life care and conducting clinical research. First, we examine the inherent tension between the goals of medicine and the goals of science. Second, we focus more specifically on the tensions between a good death and conducting clinical research in patients with a short life expectancy. We examine six domains that have been suggested for measuring a good death: physical symptoms; psychological and cognitive symptoms; economic and caregiving needs; social relationships; spiritual beliefs; hopes and expectations. For each of these domains we examine how the goals of clinical research may conflict or coincide with taking care of a patient with a terminal illness. Finally, we offer suggestions to address these tensions: (1) modify the informed consent discussion for terminally ill participants in research; (2) build a palliative care component into clinical trials; (3) attend to the needs of family caregivers of terminally ill research subjects; (4) arrange for continuity of care so that dropping out of a trial does not jeopardize medical care; (5) train clinical investigators in end-of-life care; (6) develop a counseling strategy for terminally ill participants in clinical research.