© 2002 by Oxford University Press
Journal of the National Cancer Institute, Vol. 94, No. 24, 1847-1853,
December 18, 2002
© 2002 Oxford University Press
ARTICLE |
Views of American Oncologists About the Purposes of Clinical Trials
Affiliations of authors: S. Joffe, Department of Pediatric Oncology, Dana-Farber Cancer Institute, Boston, MA, and Department of Medicine, Children’s Hospital, Boston; J. C. Weeks, Department of Adult Oncology, Dana-Farber Cancer Institute, Boston, and Department of Medicine, Brigham and Women’s Hospital, Boston.
Correspondence to: Steven Joffe, M.D., M.P.H., Center for Outcomes and Policy Research, 454 BRK Suite 21, Dana-Farber Cancer Institute, 44 Binney St., Boston, MA 02115 (e-mail: steven_joffe{at}dfci.harvard.edu).
Background: Many research subjects believe incorrectly that the primary purpose of clinical trials is to benefit the participants rather than to improve therapy for future patients. However, few data are available about how physicians view trials. Methods: We mailed surveys to a stratified random sample (n = 1120) of U.S. medical, pediatric, and other oncology specialists who were selected from the American Society of Clinical Oncology Membership Directory. Respondents were asked to select, from a list of options, their reasons for enrolling individual patients in trials and what they thought the main societal purposes of clinical trials are. We used logistic regression models to evaluate which demographic and clinical practice characteristics were associated with responses to these questions. All statistical tests were two-sided. Results: Of the 547 physicians (48.8%) who responded, 40.5% of the medical oncologists, 32.3% of the pediatric oncologists, and 62.6% of the other oncology subspecialists reported enrolling individual patients in clinical trials to improve future therapy. Most of the other respondents reported enrolling patients to ensure that they received state-of-the-art treatment. When asked about the main societal purpose of clinical trials, 72.7% of the medical oncologists, 59.4% of the pediatric oncologists, and 81.9% of the other oncology subspecialists cited improving future therapy; most of the other respondents cited ensuring state-of-the-art treatment for participants. In multivariable analysis, medical oncologists (odds ratio [OR] = 0.6, 95% confidence interval [CI] = 0.3 to 0.9) and pediatric oncologists (OR = 0.3, 95% CI = 0.2 to 0.5) were less likely than other oncologists to identify improving future therapy as the main societal purpose of clinical trials, whereas industry physicians (OR = 4.6, 95% CI = 1.1 to 20.5) chose this option more often than physicians who did not work for industry. Conclusions: Many respondents viewed the main societal purpose of clinical trials as benefiting the participants rather than as creating generalizable knowledge to advance future therapy. This view, which was more prevalent among specialists such as pediatric oncologists that enrolled greater proportions of patients in trials, conflicts with established principles of research ethics.
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