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Patients' Decision-Making Process Regarding Participation in Phase I Oncology Research

Manish Agrawal, Christine Grady, Diane L. Fairclough, Neal J. Meropol, Kim Maynard, Ezekiel J. Emanuel

From the Department of Clinical Bioethics, Warren G. Magnuson Clinical Center; Medical Oncology Clinical Research Unit, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD; Colorado Health Outcomes Program, Department of Preventive Medicine and Biometrics, University of Colorado Health Sciences Center, Denver, CO; and the Divisions of Medical Science and Population Science, Fox Chase Cancer Center, Philadelphia, PA

Address reprint requests to Manish Agrawal, MD, Department of Clinical Bioethics and National Cancer Institute, Building 10, Room 1C118, 10 Center Dr, Bethesda, MD 20892-1156; e-mail: agrawalm{at}mail.nih.gov

PURPOSE: This study assesses the decision-making process of patients enrolling in phase I oncology studies.

PATIENTS AND METHODS: Participants were eligible if they had consented to participate in a phase I cancer study at one of five cancer centers, understood English, and were older than 18 years. Trained interviewers conducted structured in-person interviews.

RESULTS: Of the 163 participants, 88% were white, 96% had health insurance, and 51% were college graduates or post graduates. Overall, 81% were aware of hospice, but only 6% had seriously considered hospice for themselves; 84% were aware of palliative care and 10% seriously considered it for themselves; and 7% considered getting no treatment at all. Overall, 75% reported moderate or a lot of pressure to participate in the phase I study because their cancer was growing, whereas 7% reported such pressure from the study investigators and 9% felt such pressure from their families. For 63% of patients, the most important information for decision making was that the phase I drug killed cancer cells; only 12% reported that the adverse effects of the drug(s) was the most useful information. More than 90% of patients said they would still participate in the study even if the experimental drug caused serious adverse effects, including a 10% chance of dying.

CONCLUSION: Patients are aware of many alternatives to phase I studies, but do not seriously consider them. Very few experience pressure from family or researchers to participate in research. Their main goal is to fight their cancer, and almost no adverse effect, including death, would dissuade them from enrolling.

Supported by the Department of Clinical Bioethics of the National Institutes of Health (NIH) and in part by NIH Grant No. R0182085 (N.J.M.).

The ideas and opinions expressed are the authors' own. They do not represent any position of policy of the National Institutes of Health, Public Health Service, or Department of Health and Human Services.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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