This Article  • Full text  • PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Contact me when this article is cited  Related Content  • Related letters  • Similar articles in this journal  Topic Collections  • Medical Ethics  • Oncology  • Statistics and Research Methods  • Randomized Controlled Trial  • Alert me on articles by topic  Social Bookmarking   What's this?

Are They Vulnerable?

Justine Seidenfeld; Elizabeth Horstmann, BA; Ezekiel J. Emanuel, MD, PhD; Christine Grady, RN, PhD

Arch Intern Med. 2008;168(1):16-20.

Phase 1 oncology trials involve risk and offer a relatively low prospect of benefit to participants. Some claim that participants constitute a vulnerable population requiring special protections. We undertook this study to determine whether phase 1 oncology trial participants have demographic and health status characteristics of a vulnerable population. We reviewed participant demographic and health status data from phase 1 trials sponsored by the Cancer Therapy Evaluation Program at the National Cancer Institute that began between 1991 and 2002 and from 11 previously published studies. Main outcome measures were median age, sex, race/ethnicity, performance status, previous therapy, educational achievement level, and health insurance coverage. Almost 10 000 participants in trials sponsored by the Cancer Therapy Evaluation Program had a median age of 57 years, 90% self-identified as white, 93% had near-normal performance status, 85% had some form of health insurance, and 92% had been previously treated for cancer; 20 000 individuals from published studies had comparable profiles. The demographic and health status characteristics of phase 1 oncology trial participants are not those of a conventional vulnerable population and suggest little reason to assume that, as a group, they have a compromised ability to understand information or to make informed and voluntary decisions.

Author Affiliations: Department of Bioethics, Clinical Center, National Institutes of Health, Bethesda, Maryland.

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati     What's this?

RELATED LETTERS

Participants in Phase 1 Oncology Research Trials Are Vulnerable
Ron Berghmans
Arch Intern Med. 2008;168(20):2287-2288.
EXTRACT | FULL TEXT  

Participants in Phase 1 Oncology Research Trials Are Vulnerable—Reply
Christine Grady, Justine Seidenfeld, Elizabeth Horstmann, and Ezekiel J. Emanuel
Arch Intern Med. 2008;168(20):2288.
EXTRACT | FULL TEXT  

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Prospective Validation of a Prognostic Score to Improve Patient Selection for Oncology Phase I Trials
Arkenau et al.
JCO 2009;27:2692-2696.
ABSTRACT | FULL TEXT  

Introduction: vulnerability in biomedical research.
Iltis
J Law Med Ethics 2009;37:6-11.
 

Vulnerability in Research: Individuals with Limited Financial and/or Social Resources.
Grady
J Law Med Ethics 2009;37:19-27.
 

First-in-Human Trial Participants: Not a Vulnerable Population, but Vulnerable Nonetheless.
Dresser
J Law Med Ethics 2009;37:38-50.
 

Participants in Phase 1 Oncology Research Trials Are Vulnerable
Berghmans
Arch Intern Med 2008;168:2287-2288.
FULL TEXT  

Participants in Phase 1 Oncology Research Trials Are Vulnerable--Reply
Grady et al.
Arch Intern Med 2008;168:2288-2288.
FULL TEXT  

The Ethics of Phase 0 Oncology Trials
Abdoler et al.
Clin. Cancer Res. 2008;14:3692-3697.
ABSTRACT | FULL TEXT