Patient advocates' role in clinical trials: perspectives from Cancer and Leukemia Group B investigators and advocates

Abstract

Background: Patient advocates are increasingly involved in cooperative group trials, single-institution cancer programs, and peer-review of research applications. The purpose of this study was to evaluate the role and value of patient advocates from the perspective of Cancer and Leukemia Group B (CALGB) advocates and investigators.

Methods: An online survey was sent to current and past (within 5 years) patient advocates and investigators. RESULTS.: Response rates were 72.7% (16 of 22) for advocates and 56.4% (102 of 181) for investigators. Patient advocates were more likely than investigators to report the following: the clinical trial process benefited from advocate involvement on committees (100% of advocates vs 72.1% of investigators; P < .05), advocates contribute to protocol development (92.8% vs 33.8%, respectively; P < .001), the cultural appropriateness of protocols (21.4% vs 10.4%, respectively; P < .05), advocates assist with patient accrual (78.6% vs 23.4%, respectively; P < .001), and advocates add value to concept development and protocol review (100% vs 63.2%, respectively; P < .001). Over half of advocates and investigators reported gaps in patient advocate knowledge and suggested that additional clinical trials training was needed. To improve clinical trials, advocates suggested their earlier involvement in protocol development and increased support from investigators. CALGB investigators recommended improving patient advocate selection and communication skills training:

Conclusions: The majority of patient advocates and investigators perceived benefits from advocate involvement in the clinical trials process; patient advocates placed more value on their role than investigators. The current results indicated that strategies to improve advocacy training and advocate-investigator communication may further enhance the role of patient advocates, and future studies that clarify the role of advocates in the prioritization and development of protocol, consent, and education materials, and on patient accrual, are warranted.