Researcher Profile
Steven Joffe, MD, MPH
Assistant Professor of Pediatrics, Harvard Medical School
Center/Program
Department
Interest
oncology
Area of Research
Ethical Challenges in Biomedical Care and Research
Contact Information
Steven Joffe, MD, MPHDana-Farber Cancer Institute
44 Binney Street
Smith 207
Boston, MA 02115
Office phone: (617) 632-5295
Fax: (617) 632-2270
E-mail: steven_joffe@dfci.harvard.edu
Preferred contact method: e-mail
Research
Our research addresses the many ethical challenges that arise in the conduct of clinical investigation, both in pediatric and adult oncology as well as in other areas of medicine. A significant part of our work focuses on measuring and improving the informed consent process for clinical trials. We developed and validated a brief instrument, the Quality of Informed Consent (QuIC), for measuring research subjects' understanding of cancer clinical trials. Using this instrument, we surveyed adult cancer patients and parents of pediatric patients who had recently agreed to participate in a clinical trial. This survey identified important deficiencies in the informed consent process, groups at risk for inadequate understanding, and interventions that might improve the outcome of the consent process. We also studied how physicians conceptualize clinical research, showing that many oncologists view research primarily as a means for getting state-of-the-art therapies to patients rather than as a mechanism for answering important scientific and clinical questions.
We are also interested in better understanding the risks and benefits of participation in clinical trials. In a recent systematic review of the literature, we found that little rigorous evidence exists for the prevalent belief that cancer patients taking part in clinical trials have better outcomes than similar patients who receive treatment off protocol. At the same time, we demonstrated that there is a measurable but slight advantage to assignment to the experimental rather than the standard arm of an adult cooperative-group cancer randomized trial.
Other research is exploring the ethical and regulatory challenges that arise when conducting laboratory research involving human specimens. For future research purposes, we are currently studying attitudes of cancer patients towards storage of tissue samples, as well as attitudes towards the return of individual results of genetic tests done in the research context. Additional areas of study include the development of children's capacity to reason and decide about research participation, and the nature and practices of accountability in the clinical research enterprise.
Recent Awards
- Award for Excellence in Human Research Protections (Innovation), Health Improvement Institute, 2002
Biography
Dr. Joffe received his MD from the University of California, San Francisco (UCSF), in 1992 and his MPH from UC Berkeley in 1996. He was a resident in pediatrics at UCSF and a fellow in hematology/oncology at Dana-Farber Cancer Institute (DFCI) and Children's Hospital Boston (CHB). Later he completed the Harvard Pediatric Health Services Research Fellowship and was a faculty fellow at the Harvard Center for Ethics and the Professions.
In 2000, he joined the staff of CHB and DFCI, where he has served as an ethicist since 2001. Dr. Joffe specializes in Stem Cell Transplantation.
Select Publications
- Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC. Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet. 2001;358(9295):1772-7.
- Joffe S, Harrington DP, George SL, Emanuel EJ, Budzinski LA, Weeks JC. Satisfaction of the uncertainty principle in cancer clinical trials: retrospective cohort analysis. BMJ 2004;328:1463.
- Peppercorn JM, Weeks JC, Cook EF, Joffe S. Comparison of outcomes in cancer patients treated within and outside clinical trials: conceptual framework and structured review. Lancet 2004;363:263-70.
- Joffe S, Fernandez CV, Pentz RD, Ungar DR, Mathew NA, Turner CW, Alessandri AJ, Woodman CL, Singer DA, Kodish E. Involving children in decision-making about research participation. J Pediatr. 2006;149(6):862-8.
- Mello MM, Joffe S. Compact versus contract: an ethical and legal analysis of industry sponsors' obligations to research subjects. N Engl J Med. 2007;356(26):2737-43.
- Joffe S, Mello MM, Cook EF, Lee SJ. Advance care planning in patients undergoing hematopoietic cell transplantation. Biol Blood Marrow Transplant. 2007;13(1):65-73.
- Peppercorn JM, Burstein H, Miller FG, Winer E, Joffe S. Self-reported practices and attitudes of U.S. oncologists regarding off-protocol therapy. J Clin Oncol 2008;26(36):5994-6000.
- Kesselheim JC, Johnson J, Joffe S. Pediatricians' reports of their education in ethics. Arch Pediatr Adol Med 2008;162(4):368-73.
- Thornley I, Eapen M, Sung L, Lee SJ, Davies SM, Joffe S. Private cord blood banking: experiences and views of pediatric hematopoietic cell transplantation physicians. Pediatrics 2009;123(3):1011-7.
- Rose SL, Krzyzanowska MK, Joffe S: Relationships between authorship contributions and authors financial ties among oncology clinical trials. J Clin Oncol 2010 (epub ahead of print January 11, 2010).
- Kesselheim JC, Johnson J, Joffe S. Ethics consultation in free-standing childrens hospitals: results from a survey of pediatric clinical ethicists. Pediatr 2010 (in press).
