JOURNAL OF PALLIATIVE MEDICINE Volume 5, Number 5, 2002 © Mary Ann Liebert, Inc. End-of-life Care for Terminally Ill Participants in Clinical Research MANISH AGRAWAL, M.D., 1,2 and MARION DANIS, M.D. 1 ABSTRACT 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 at- tention 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 ten- sions between a good death and conducting clinical research in patients with a short life ex- pectancy. 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 pa- tient with a terminal illness. Finally, we offer suggestions to address these tensions: (1) mod- ify the informed consent discussion for terminally ill participants in research; (2) build a pal- liative 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. 729 INTRODUCTION T HERE HAS BEEN A CONCENTRATED effort to im- prove end-of-life care in the United States yet little attention has been paid to the unique con- cerns at the end of life for participants in clinical research. In this paper we focus attention on and offer an analysis of the needs of these individu- als and how to address them. The care of patients with a short life expectancy who are enrolled in clinical trials is particularly compelling because research will always likely focus on illnesses that remain untreatable with extant conventional ther- apy and hence life-threatening. The valuable in- formation learned from conducting phase 1 clin- ical trials will primarily benefit future patients whose illnesses would otherwise be fatal. For the patient who chooses to participate in a trial, there is no guarantee of benefit and there is the possi- bility of harm and discomfort. Given that these 1 Department of Clinical Bioethics, and the 2 National Cancer Institute, National Institutes of Health, Bethesda, Mary- land. The opinions expressed in this manuscript are those of the authors and do not reflect the policies of the National Institutes of Health or the Department of Health and Human Services.