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

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 hav
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Contact: Bill Schaller
william_schaller@dfci.harvard.edu
617-632-5357
Dana-Farber Cancer Institute
22-Nov-2001


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