Communication of the essential elements of informed consent (IC) for research: A RIAS analysis of phase I clinical trial encounters.

Abstract

6045 Background: Advanced cancer patients (ACP) in phase I clinical trials are unable to recall many important elements of IC, yet the content of discussion between physician-investigators (PI) and ACP consenting to such trials has not been well described. Methods: Clinical encounters were recorded between 131 ACP entering phase I trials and 25 PIs at three institutions (University of Chicago; Johns Hopkins; and Duke University). ACP completed follow-up questionnaires 1 week later to assess understanding of IC elements, e.g., research purpose of phase I trials. Recordings were analyzed using the Roter Interaction Analysis System (RIAS), and coding for terms associated with IC elements. Results: To date, 87 ACP-PI encounters have been analyzed. Average length of encounters: 30.4 min (range: 5.7-77.8 min). ACP demographics include: median age 60y (33-83); 55% female; 88% Ca; 55% < $60,000. PIs were coded as stating: 1) The purpose of a phase I trial as determining dosage/toxicity in 40% of encounters; 2) Physical risk of a trial in 70% of the encounters; 3) Life-threatening risks in 10% of the encounters; 4) Potential benefits gained by subject participation in the trial related to improvement in quality of life or stabilization of disease in 63% of encounters; and 5) Trial alternatives in 58% of the encounters. Within follow-up interviews, 26% of ACP described the purpose of a phase I trial as determining drug safety; 67% described alternatives to trial participation. An association existedbetween coding for PI statements re: the purpose of a phase I trial as dosage/toxicity and ACP correctly recalling the purpose of the trial (86% vs. 14%, p < 0.05). Conclusions: PI communication and subsequent ACP understanding of important elements of IC remain inadequate in the phase I trial setting. No significant financial relationships to disclose.