New study provides mixed report card on informed consent to cancer clinical trials

November 22, 2001

BOSTON -- While most cancer patients enrolled in clinical trials understand the primary purpose of the research, nearly one quarter of the participants do not realize that clinical trials are conducted mainly to benefit future patients, not themselves. In addition, many patients are unaware that these experimental treatments are not yet proven to be better than available alternatives, according to a study by Boston researchers that appears in the Nov. 24 issue of The Lancet.

These "therapeutic misconceptions" are common among patients - and among some doctors as well - even after signing informed consent papers asserting that they fully comprehend the pros and cons of the clinical trials.

In the study, 205 adult cancer patients who had recently enrolled in clinical trials in Boston completed questionnaires about their understanding of the studies. They were participating in Phase I studies looking at safety and side effects, Phase II studies looking for initial evidence of medical benefit, and Phase III studies in which large numbers of patients are randomly assigned to receive either the standard or investigational therapy in order to evaluate which is better.

The researchers found that 71 percent of respondents knew that they might not get any direct medical benefit from the trial, and less than 40 percent recognized that participation might carry additional risk or discomfort when compared with standard therapies.

At the same time virtually all were highly satisfied with the informed consent process, and almost none reported pressure to participate from physicians.

The researchers noted several factors associated with greater knowledge about the trial. Participants who performed better were more likely to have a college education, to speak only English at home, to have read their consent forms carefully, to have had a nurse present during the consent discussion, to have taken time to consider their enrollment decision, and to have received a simplified consent form based on a template recently published by the National Cancer Institute.

The hospitals involved in the study -- the Dana-Farber Cancer Institute, Massachusetts General Hospital and Brigham and Women's Hospital - have been working to improve participants' understanding of clinical trials for several years. For example, they continue to expand the use of translators for clinical trials. They also are using simplified consent forms for all studies, publishing sets of guidelines for informed consent to research, and strengthening educational programs for physicians and other professionals involved in clinical research.

"Cancer patients who participate in clinical trials generally receive treatment that is as good as they would receive outside of the trial," said the lead author of the report, Steven Joffe, MD, MPH, instructor in pediatrics at Dana-Farber and Children's Hospital. "Nevertheless, it is important to realize that trials are designed mainly to improve treatment for the future. Patients today benefit from the knowledge gained in previous clinical trials. Continued trial participation is essential because, without it, we will be unable to make progress for the next generation of cancer patients."

In a separate phase of the study, 67 percent, of the health care professionals whose patients had enrolled in the trials completed similar questionnaires. To the researchers' surprise, only 46 percent of professionals agreed that trials are done mainly to improve treatment for future patients. Most did, however, recognize that research participants might not benefit from enrolling in the trials.

To explain these findings, the researchers said that doctors who take part in clinical trials are frequently in a conflict situation. On the one hand, they want to further research and improve treatment for the future. On the other hand, they are committed to helping the patients in front of them. But these two obligations sometimes conflict, leaving physician-investigators with a dilemma.

"It is critical that providers and investigators appreciate this potential conflict if they are to help participants distinguish research goals from therapeutic intentions," says Jane Weeks, MD, MSc, of the Dana-Farber, senior author of the report.
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In addition to Joffe and Weeks, authors include E. Francis Cook, ScD, of the Division of General Medicine at Brigham and Women's; Paul D. Cleary, PhD, of the Department of Health Care Policy at Harvard Medical School, and Jeffrey W. Clark, MD, of the Division of Hematology and Oncology at Massachusetts General Hospital.

The study was funded by the Agency for Healthcare Research and Quality.

Dana-Farber Cancer Institute (www.dana-farber.org) is a principal teaching affiliate of the Harvard Medical School and is among the leading cancer research and care centers in the United States. It is a founding member of the Dana-Farber/Harvard Cancer Center (DF/HCC), a designated comprehensive cancer center by the National Cancer Institute.

Dana-Farber Cancer Institute

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