Building a Framework for Equity Enrollment in Oncology Trials | Page 3

Figure 2. Barriers Within the Accrual Process 8-20 Reduced awareness of cancer clinical trials has been reported in African American patients, individuals with an annual income of less than $25,000, or those without a college degree. Yet many clinical trials are sponsored by private corporations, and even government-funded trials face challenges in creating equity in enrollment. And although multiple barriers to enrollment have been identified and reported, documented solutions for breaking barriers are few. Here we describe reported barriers to underserved oncology patients and relate them to specific stages of a conceptual model of the enrollment process. Understanding how patients approach enrollment and where they encounter impediments may be useful for identifying strategies for enrollment outreach in individual communities or disease populations. Conceptual Model of the Accrual Process ยป The conceptual model of the accrual process describes three fundamental steps required for patients to enroll in clinical trials: awareness, opportunity, and decision-making. Patients accept or refuse participation in a clinical trial only after being aware that the study is being conducted and having an opportunity to participate.7 Given the opportunity to participate, an individual may seek additional information regarding the potential harms or benefits of participation The conceptual model serves as a framework to categorize barriers based on their effects on awareness, opportunity, and decisions Stage 1: Awareness of Clinical Trials Not surprisingly, patient lack of awareness regarding cancer clinical trials is associated with reduced participation in cancer clinical trials.8 Reduced awareness of cancer clinical trials has been reported in African American patients, individuals with an annual income of less than $25,000, or those without a college degree.8 Lack of knowledge about the origins of cancer is also a barrier to enrollment.9,10 Contributing to the lack of awareness is a lack of culturally appropriate information about cancer and cancer research.10 about participation. clinipace.com 2