Decision-Making and Participation in Clinical Trials

The aim of this study was to compare, theoretically, attitudes towards participating or declining to participate in a hypothetical randomized controlled trial (RCT) involving three comparable breast cancer patient groups surveyed prospectively (non-metastatic cancer treated with standard chemotherapy): some patients were invited to participate in the clinical RCT (201 acceptances, 66 refusals) and others were not (n = 188). Patients' acceptance to participate reflected their physicians' approval, whereas refusal was usually a personal choice. When proposing RCTs, physicians must address patients' negative preconceptions about randomization. Physicians should thoroughly discuss the reasons for and importance of randomization as well as the other aspects of participating in clinical trials in order to provide patients with all the information they need to make informed decisions.