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

According to a study that appeared in the Nov. 24, 2001, issue of The Lancet, nearly one quarter of cancer patients who participate in clinical trials do not realize that the trials are conducted mainly to benefit future patients, not themselves. Many patients are unaware that experimental treatments are not yet proven to be better than alternatives. 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 process of giving their informed consent to participate in the clinical trials, and almost none reported pressure to participate from physicians. 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. “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, Harvard instructor in pediatrics at Dana-Farber and Children’s Hospital.