© 2003 by Oxford University Press
Journal of the National Cancer Institute, Vol. 95, No. 8, 631,
April 16, 2003
© 2003 Oxford University Press
CORRESPONDENCE |
RESPONSE: Re: Views of American Oncologists About the Purposes of Clinical Trials
Affiliations of authors: S. Joffe, Department of Pediatric Oncology, Dana-Farber Cancer Institute, and Department of Medicine, Children’s Hospital, Boston, MA; J. C. Weeks, Department of Medical Oncology, Dana-Farber Cancer Institute, and Department of Medicine, Brigham and Women’s Hospital, Boston.
Correspondence to: Steven Joffe, M.D., M.P.H., Dana-Farber Cancer Institute, 44 Binney St., Boston, MA 02115 (e-mail: steven_joffe{at}dfci.harvard.edu).
We welcome the thoughtful correspondence by Anderson et al. about our recent paper on American oncologists’ views of clinical trials (1), and we second their comments. These investigators correctly highlight the exemplary work of the pediatric oncology community over the past few decades in improving outcomes for children with cancer. The clinical trials program in pediatric oncology, which has served as the foundation for these advances, constitutes an international model for sustained and systematic improvement in the state of the clinical art (2).
We particularly appreciate the authors’ characterization of the standard arm of a randomized phase III trial as state-of-the-art treatment that is available to patients whether or not they enroll in a trial. This characterization, which implies that the experimental arm represents a (generally reasonable) deviation from the standard of care, brings much-needed clarity to our thinking about clinical research.
The data we reported suggest that the ethical challenges inherent in all clinical research may be particularly acute in pediatric oncology, perhaps because of the unparalleled integration of trials into the routine care of pediatric cancer patients. To its credit, the pediatric oncology community has engaged in valuable dialogue and research about the complexities of conducting clinical trials among children with cancer (3–6). We join Anderson et al. in underscoring the fun-damentally ethical nature of this research enterprise and salute the dedication of all who contribute to this important effort.
REFERENCES
1 Joffe S, Weeks JC. Views of American oncologists about the purposes of clinical trials. J Natl Cancer Inst 2002;94:1847–53.
2 Pear R. Clinton to order Medicare to pay new costs. The New York Times 2000 June 7; A24.
3 Shurin S. Bioethics Committee: report and invitation. Children’s Oncology News 2002;2:14. Available at: http://www.childrensoncologygroup.org/COGPUBLIC/conv2n4-2002.pdf.[Last accessed: 02/12/2003.]
4 Simon C, Eder M, Raiz P, Zyzanski S, Pentz R, Kodish ED. Informed consent for pediatric leukemia research: clinician perspectives. Cancer 2001;92:691–700.[CrossRef][Web of Science][Medline]
5 Kodish ED, Pentz RD, Noll RB, Ruccione K, Buckley J, Lange BJ. Informed consent in the Children’s Cancer Group: results of preliminary research. Cancer 1998;82:2467–81.[CrossRef][Web of Science][Medline]
6 Levi RB, Marsick R, Drotar D, Kodish ED. Diagnosis, disclosure, and informed consent: learning from parents of children with cancer. J Pediatr Hematol Oncol 2000;22:3–12.[CrossRef][Web of Science][Medline]
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