Decision-Making Process Related to Participation in Phase I Clinical Trials : a Nonsystematic Review of the Existing Evidence

Due to the lack of other treatment options, patient candidates for participation in phase I clinical trials are considered the most vulnerable, and many ethical concerns have emerged regarding the informed consent process used in the experimental design of such trials. Starting with these considerations, this nonsystematic review is aimed at analyzing the decision-making processes underlying patients' decision about whether to participate (or not) in phase I trials in order to clarify the cognitive and emotional aspects most strongly implicated in this decision. Considering that there is no uniform decision calculus and that many different variables other than the patient-physician relationship (including demographic, clinical, and personal characteristics) may influence patients' preferences for and processing of information, we conclude that patients' informed decision-making can be facilitated by creating a rigorously developed, calibrated, and validated computer tool modeled on each single patient's knowledge, values, and emotional and cognitive decisional skills. Such a tool will also help oncologists to provide tailored medical information that is useful to improve the shared decision-making process, thereby possibly increasing patient participation in clinical trials.