Cancer specialists in disagreement about purpose of clinical trials

December 17, 2002

The primary purpose of clinical trials is to advance therapy for future patients. However, a new study reveals that many cancer specialists believe that the main purpose of these trials is to provide state-of-the-art treatment to patients considering trial participation. This finding appears in the December 18 issue of the Journal of the National Cancer Institute.

Physicians who conduct clinical trials have a responsibility to both their patients and to the larger societal purpose of contributing to scientific knowledge. Although many clinical trial participants believe that the goal of clinical trials is to benefit them rather than future patients, little is known about how physicians view the purpose of clinical trials.

Steven Joffe, M.D., and Jane C. Weeks, M.D., of the Dana-Farber Cancer Institute in Boston, surveyed 1,120 cancer physicians across the United States, including medical oncologists, pediatric oncologists, and other cancer subspecialists (i.e., gynecologic, radiation, surgical, and urologic oncologists). The physicians were asked about their reasons for enrolling individual patients in trials and what they viewed as the main societal purpose of the trials.

The authors found substantial differences among the specialties in views about trials. Most (64.1%) pediatric oncologists, compared with 42.8% of medical oncologists and 25.2% of other cancer subspecialists, reported enrolling individuals in trials to provide those patients with state-of-the-art treatment. When asked about the societal purposes of clinical trials, 38.2% of pediatric oncologists, compared with 19.5% of medical oncologists and 13.1% of other cancer subspecialists, said that the main purpose of trials was to ensure state-of-the-art treatment for trial participants. At the same time, fewer pediatric oncologists viewed clinical trials as intended primarily to improve treatment for future patients.

To explain their findings, the authors suggest that "there may be a sincere belief in the oncology community that, through clinical trials, we have succeeded in harmonizing perfectly the objectives of patient care and those of scientific advancement." This belief may be most prominent among pediatric oncologists, who enroll the largest proportion of their patients in clinical trials. They conclude that "whether oncology has perfectly aligned research and clinical care, or whether such reconciliation is even logically possible, are critical questions that require sustained discussion and debate."

In an accompanying editorial, Franklin G. Miller, Ph.D., of the Department of Clinical Bioethics at the National Institutes of Health, examines the ethical significance of this study. He points out that clarity about the differences and potential conflicts between patient care and clinical investigation is ethically important at all stages of clinical research, from study design, to subject recruitment and selection, to deciding when to stop the study because of adverse events. "Correctly understanding the purpose of clinical trials is only one dimension of recognizing how treatment in the context of a clinical trial differs from personalized medical care in fundamentally important ways," he says.
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Contact: Bill Schaller, Dana-Farber Cancer Institute, 617-632-5357; fax: 617-632-4069, william_schaller@dfci.harvard.edu

Editorial: Dianne Needham, NIH Clinical Center Communications, 301-594-5788; fax: 301-402-2984, dneedham@cc.nih.gov

Joffe S, Weeks J. Views of American oncologists about the purposes of clinical trials. J Natl Cancer Inst 2002;94:1847-53.

Editorial: Miller F. Ethical significance of ethics-related empirical research. J Natl Cancer Inst 2002;94:1821-2.

Note: The Journal of the National Cancer Institute is published by Oxford University Press and is not affiliated with the National Cancer Institute. Attribution to the Journal of the National Cancer Institute is requested in all news coverage.

Journal of the National Cancer Institute

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