BOSTONMisconceptions about cancer clinical trials are common among trial
participants, according to a survey of 205 patients and 61 providers conducted
at the Dana-Farber Cancer Institute, Brigham and Women’s Hospital, and
Massachusetts General Hospital.
Most of the participants said they were satisfied with the informed consent
process and considered themselves well informed. Nonetheless, 74% did not
recognize that their treatment was considered nonstandard; 62% did not
understand the potential for risk; and 71% were not aware that the treatment
Among the participants, 25% did not agree with the statement that trials are
performed primarily to benefit future patients, a misconception shared by 54%
of the providers.
Among the factors associated with better knowledge of clinical trials were
college education, speaking only English at home, use of the National Cancer
Institute consent form template, not signing the consent form at initial
discussion, presence of a nurse at the consent discussion, and careful reading
of the consent form (Lancet 358:1772-1777, 2001).
"Although there were few non-native English speakers, their reduced
scores are of great concern," said lead author Jane C. Weeks, MD.
"Efforts are needed to ensure that their consent is adequately informed,
perhaps by expanding the use of interpreters and translated consent
forms." She also suggested several simple interventions to improve
understanding, including use of a structured consent template and the presence
of a professional third party such as a nurse.