Discoveries
Study finds informed-consent process needs improvement
Steven Joffe, MD, MPH
Though most cancer patients enrolled in clinical trials understand the primary purpose of the research, nearly a quarter of them do not realize that such studies are conducted mainly to benefit future patients rather than themselves. Also, many enrolled patients don't know these treatments-under-study are not yet proven to be better than available alternatives, according to a recent report by Dana-Farber/Partners CancerCare investigators.
These "therapeutic misconceptions" are common among patients — and among some doctors — even after patients have signed informed- consent forms asserting that they fully comprehend the pros and cons of the research. Overall, the authors say, the study reveals "important flaws" in participants' understanding of cancer clinical trials, and suggests a need to improve the process of obtaining informed consent.
The study, led by Steven Joffe, MD, MPH, of Dana-Farber and Children's Hospital Boston, and Jane Weeks, MD, MSc, of Dana-Farber was based on the results of questionnaires completed by 205 adult cancer patients participating in clinical trials for new treatments at DFCI, Massachusetts General Hospital, and Brigham and Women's Hospital.
Jane Weeks, MD, MSc
Most respondents said they were highly satisfied with the informed-consent process, but the researchers found that only 71 percent of them knew they might not get any direct medical benefit from the trial. Less than 40 percent recognized that participation might carry increased risk or discomfort when compared with standard therapies.
The hospitals involved in the study — Dana-Farber, Brigham and Women's, and Mass General — have been working to improve understanding of clinical trials for several years. They have expanded the use of translators, developed simplified consent forms for patients, and instituted stronger educational programs for caregivers involved in clinical research.
More than 300 therapeutic clinical trials are under way for adult patients through DanaFarber/Partners CancerCare, and others are being conducted through the pediatric program.
The informed-consent study was published in the journal The Lancet.
