The October 10, 2014 issue of the Journal of Clinical Oncology carries the article, “Hope and Persuasion During Informed Consent.” It reports an assessment of informed consent conferences between pediatric oncologists and children with incurable cancer, and their patients, at six centers participating in a Phase 1 clinical trial between 2008 and 2011. Recall that, in drug development, “Phase 1” refers to the earliest stage of human testing, when an experimental drug may not have been given to people before, and little to nothing about its safety and efficacy is known. In many areas of medicine, Phase 1 studies are very limited, and done in healthy volunteers. In cancer medicine, because the drugs may be quite toxic, and there is great need for new treatments, these studies are done in people with cancer—usually, people who have failed to be cured by previous therapy, and for whom there is no known prospect for cure with any treatment.
The circumstances of oncology Phase 1 trials give rise to the “therapeutic misconception,” which is a fancy way of saying “false hope,” and about which much has been written. After all, most experimental cancer drugs fail, and few show much sign of success in Phase 1, where the goal is not so much success as checking safety.
In the research in question, the investigators, after obtaining informed consent to do so, observed and made audiotapes of the conversations about informed consent for the cancer drug trial in question. (Further details about the trial, such as what drugs were being tested, was not provided.) The researchers used a classification system to count the number of hopeful or realistic statements made by the doctors in these conferences, as well as the number of statements that could have been construed as attempts to persuade or as bending over backward to avoid appearing to be pressuring a child and his/her parents to consent to having the child be in the trial.
The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.