How Informed is Informed Consent?

A new study published in the British medical journal The Lancet has taken to task the quality and complexity of informed consent procedures for patients enrolling in clinical trials.

Dr. Jane Weeks of the Dana-Farber Cancer Institute in Boston and colleagues wrote that while most cancer patients enrolled in clinical trials appear understand the primary purpose of the research, nearly one quarter of the them do not realize that clinical trials are conducted mainly to benefit future patients. In addition, many patients are unaware that these experimental treatments are not yet proven to be better than currently available alternatives.

These "therapeutic misconceptions" are common among patients, they wrote, and even among some doctors as well.

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 of the enrollees 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;
• Speak only English at home;
• Have read their consent forms carefully;
• Have had a nurse present during the consent discussion;
• Have taken time to consider their enrollment decision; and,
• Have received a simplified consent form based on a template recently published by the National Cancer Institute.

"Cancer patients who participate in clinical trials generally receive treatment that is as good as they would receive outside of the trial," said Dr. Steven Joffe of Dana-Farber, the lead author of the report. "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.

"Misconceptions about cancer trials are frequent among trial participants, and physician/investigators might share some of these misconceptions," the authors wrote. "Efforts to educate providers and participants about the underlying goals of clinical trials are needed."

SOURCES:
Lancet, November 24, 2001; 358:1772-1777
Dana-Farber Cancer Research Institute (http://www.dana-farber.org)
U.S. Agency for Healthcare Research and Quality (http://www.ahcpr.gov)

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